Articles Posted in Medical Devices

leerink.pngOn February 12 and 13, 2014, Leerink Partners LLC (“Leerink”) held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference includes emerging themes in healthcare, where Leerink’s equity analysts moderate discussions with MEDACorp specialists to provide unique and timely insights.

In addition to the company presentations, this year’s line up featured the following panels or keynote speakers with some observed comments or trends:

• Panel: The Future of Medical Devices in an Evolving Landscape: A Shifting Emphasis to Patient Monitoring and Customizable Solutions

  • Patients view surgeons that incorporate robotics in their practice as the better doctors, driving more surgeons to utilize them in their practice. As surgeons become more familiar with these devices, patients may have more options for surgical procedures and implants.
  • Larger companies are looking at controlling infections caused by implanted medical devices with special coatings–either anti-infectives or antibiotics, particularly for use in higher-risk patients. There is an increasing need, however, for implants to have built-in tools for monitoring the devices. But as medical devices become more complex, such as hip, knee, or total joint replacements, these devices will require preapproval marketing applications (“PMAs”) with clinical data rather than less costly and time-consuming 510(k)-type premarket clearance applications. Since PMAs cost companies more than 510(k) applications, these newer devices will cost third party payors and patients more.
  • Hospitals continue to be under a lot of pressure not to lose patients, so they may seek lower margins by having surgeons add anti-infective coatings or antibiotics rather than purchasing more costly versions with the coatings or by importing “generic” implants from other countries that may not be as rugged as the versions cleared for use in the U.S. FDA’s new unique device identifiers and improved monitoring, however, may reduce use of such imported devices with unclear pedigrees.

Continue reading

Throbbing_migraine_headache.gifLast Friday, FDA allowed marketing of Cerena TMS, the first medical device to relieve pain caused by migraine headaches that are preceded by an aura. “Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, Director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (“CDRH”).

A migraine is a chronic, neurological disorder characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms. Typically a migraine headache is unilateral (i.e., affecting one half of the head) and pulsating in nature, lasting from 2 to 72 hours. Migraines may be associated with nausea, vomiting, photophobia (increased sensitivity to light), phonophobia (increased sensitivity to sound), and migraine headache pain is generally aggravated by physical activity. Up to one-third of people with migraine headaches perceive an aura. An aura is a visual, sensory, or motor disturbance immediately preceding the onset of a migraine attack. Occasionally an aura can occur with little or no headache following it.

Cerena TMS, manufactured by eNeura Therapeutics (“eNeura”) in Sunnyvale, California, is a prescription medical device used after the onset of pain associated with migraine headaches preceded by an aura. FDA reviewed Cerena TMS under an automatic class III designation (de novo) summary option. This option is an alternate pathway to classify novel devices of low to moderate risk that are “not substantially equivalent” to a legally-marketed predicate device. Devices that classified through the de novo process (and subsequently cleared as 510(k) type medical devices class I or II) may be marketed and used as predicate devices for future 510(k) submissions. Devices that are classified under class III otherwise require a premarket approval application (“PMA”), which is a most stringent type of medical device marketing application.
Continue reading

23andme.jpg23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA’s November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to “immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, “PGS”] until such time as it receives FDA marketing authorization for the device.” While 23andMe will discontinue access to health-related services, 23andMe will continue to provide access to raw genomic data as well as ancestry-related applications. Also, customers who purchased 23andMe prior to FDA’s Warning Letter will still have access to health-related results.

The Warning Letter deemed the PGS a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). 21 U.S.C. 321(h). Section 201(h) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” or is “intended to affect the structure or any function of the body.” FDA determined that the PGS fell within this definition, because it was marketed as providing, “health reports on 254 diseases and conditions.” In particular, 23andMe was marketed as a “first step in prevention” for diseases like diabetes, coronary heart disease, and breast cancer.

FDA is particularly concerned about the “potential health consequences that could result from false positive or false negative assessments for high-risk indications.” For example, a false positive BRCA-related risk assessment [A BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2. Harmful mutations in these genes produce a hereditary breast-ovarian cancer syndrome in affected families.] Mutations in BRCA1 and BRCA2 are uncommon, and breast cancer is relatively common, so these mutations consequently account for only five to ten percent of all breast cancer cases in women.[may lead to unnecessary prophylactic surgery or chemoprevention. On the other hand, a false negative may lead to a failure to appreciate actual risk. FDA was also concerned about drug response assessments, such as warfarin sensitivity or clopidogrel response. For example, a false positive BRCA-related risk assessment [a BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2 that is associated with a hereditary breast-ovarian cancer syndrome in affected families] may lead to unnecessary prophylactic surgery or chemoprevention.
Continue reading

medical app.pngOn September 25, 2013, FDA issued a final Guidance for Industry and Food and Drug Administration Staff entitled, “Mobile Medical Applications“. This Guidance discusses FDA’s intention to oversee the use of mobile applications (“apps”) that qualify as medical devices and that pose a risk to the user if they do not function as intended. These “mobile medical apps” meet the definition of a medical device, and are either intended “to be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device.” Section 201(h) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”) defines a device as

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . .
[I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . .
[I]ntended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Author's photo

Written by Julie E. Kurzrok

Other Posts By This Author

FDA places mobile medical apps in the same category of risk as currently regulated devices and intends to regulate them in the same way. The Guidance aims to assist manufacturers in determining whether a product qualifies as a mobile medical app and, if so, provides FDA’s regulatory requirements. FDA sets forth three types of mobile medical apps that it intends to apply regulatory oversight to:

  1. Mobile apps that connect to medical devices and are extensions of these devices that control, display, store, analyze, or transmit data from the medical device.

    For example: an app that controls the delivery of insulin by transmitting signals to an insulin pump.

  2. Mobile apps that transform the mobile platform into a regulated medical device.
  3. For example: an app that attaches electrocardiogram electrodes to a mobile platform to measure, store, and display electrocardiogram signals.

  4. Mobile apps (software) that perform patient-specific analyses and then provide patient-specific diagnoses or treatment recommendations.
  5. For example: an app that calculates radiation dosages or creates dosage plans for radiation therapy

Continue reading

UDIdevice.bmpFDA continues to be late in issuing its final rules to implement the unique device identifier (“UDI”) system authorized in 2007. Congress had requested that FDA finalize the rule by June 19, 2013, but FDA’s latest action has been its proposed rules published in the Federal Register on July 10, 2012.

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help FDA identify product problems more quickly, better target recalls and improve patient safety.

FDA is also reportedly creating a database that will include a standard set of basic identifying elements for each UDI, which it plans to make generally available to the public so that medical device users can easily find more information about specific devices. The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including any personal privacy information.
Continue reading

ADHDBrainWaveDevice.jpgOn July 15, FDA announced its approval of the first brain- function-based medical device to help diagnose attention deficit hyperactivity disorder (“ADHD”) in children and adolescents. The approved device, the Neuropsychiatric Electroencephalogram-Based Assessment Aid (“NEBA”) System, uses an electroencephalogram (“EEG”) to measure brain waves with sensors attached to a child’s head, which are wired to a computer. After fifteen to twenty minutes of information-gathering, it provides a read-out of the types and timing of electrical impulses, i.e., waves, emitted by brain nerve cells. Because two kinds of brain waives–theta and beta–may be more common in ADHD children, physicians can use this information to confirm an ADHD diagnosis or direct further diagnostic testing.

EEG technology has been around since the early 1900s and is often used to diagnose sleep disorders, measure unconsciousness, evaluate the brain post-head trauma, and monitor the brain during surgery. ADHD, which results in attention difficulties, hyperactivity, impulsivity and behavioral problems, is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of U.S. adolescents have ADHD and the average age of diagnosis is seven years. “Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam,” explained Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health (“CDRH”)

The manufacturer of the NEBA System, NEBA Health of Augusta, Georgia, provided FDA with data including a clinical study that evaluated 275 children and adolescents (ages 6 to 17 years) with attention/behavioral issues, using both the approved device and standard diagnostic testing such as questionnaires and physical exams. An independent group of ADHD experts also reviewed the data and reached a consensus as to whether each subject had ADHD. According to FDA, the side-by-side results “showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone.”
Continue reading

FLH Partner Brian J. Malkin will attend the Massachusett’s Biotechnology Council’s (“MassBio’s”) Annual Meeting in Cambridge, Massachusetts on March 14-15, 2013. FLH is a member of MassBio, reflecting FLH’s commitment to the development and promotion of new biological and related products. Each year, the MassBio Annual Meeting focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. The meeting program is pulled together by a Steering Committee of leaders in the industry and the agenda encompasses keynote presentations, panel discussions, interactive working sessions, and extensive networking opportunities for all MassBio members. This year, keynote presentations feature John Crowley, Chairman & CEO of Amicus Therapeutics, Inc. and FDA Commissioner Margaret A. Hamburg, M.D. Key topics of interest include personalized medicine and companion diagnostics, biosimilars, RNA therapeutics, healthcare reimbursement strategies, research resource sharing opportunities and a variety of orphan drug candidate topics. Mr. Malkin looks forward to seeing you and catching up on the latest biotechnology developments with some of the best biotechnology leaders in the Massachusetts area and beyond.

On January 28, 2013, consumer-advocacy group Public Citizen filed a letter “in response” for FDA to reconsider its August 8, 2012 denial of the group’s petition that asked FDA to withdraw its approval for a medical device directed to stent technology. Public Citizen’s original petition urged the withdrawal of approval for and recall of Stryker Corporation’s (“Stryker’s”) Wingspan Stent System with Gateway PTA Balloon Catheter (“Wingspan Stent”), which is used to treat narrowing of the blood vessels in the brain.

In its January 28 letter, Public Citizen claimed that FDA denied the petition based on flawed reasoning. Specifically, Public Citizen argued that FDA’s decision minimized the importance of crucial scientific evidence indicating that the Wingspan Stent is ineffective and, furthermore, that it is more harmful to patients experiencing intracranial narrowing of the blood vessels when compared to alternative forms of treatment. Public Citizen also criticized FDA’s attempt at comprise by narrowing the proposed indication of the stent in response to the scientific data outlined in the petition. Public Citizen argued that such attempts fell far short of being sufficient to ensure the safety of patients that might consider using Stryker’s medical device.

The Wingspan Stent is a class III medical device that comprises a stent with a balloon catheter and, until recently, was indicated for use “in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis [(a narrowing of the blood vessels that supply blood to the brain)] that are accessible to the system.” In simple terms, the device uses a self-expanding tube that is inserted into a blocked artery in the brain with the “goal of increasing blood flow and preventing strokes in patients who have experienced repeat strokes, even after taking medication to prevent blood clotting.”
Continue reading

communicate.jpgOn March 5, FDA issued a new draft guidance, “Types of Communication During the Review of Medical Device Submissions.” During the development of the various medical device user fee amendments (“MDUFA”), the discussion of improving communications between device applicants and FDA was suggested, described as an Interactive Review. The collection of additional funds from MDUFA-related activities will enable FDA to improve the device review process and help meet certain performance goals incorporated into MDUFA. Some of the suggested communications included Acceptance Review, Substantive Interactions, Interactive Review, and, where applicable, Missed MDUFA Goals.

The purpose of Acceptance Review communications are to: (1) identify the lead reviewer or Regulatory Project Manager assigned to the submission and (2) confirm acceptance of the submission or notify the submitter that the submission was not accepted based upon the review of objective acceptance criteria. FDA aims to make these communications within 15 days of receipt of a 510(k), original premarket approval application (“PMA”), or a Panel-Track PMA Supplement, with such confirmation by fax, e-mail, or other written communication.

Substantive Interactions tell applicants that FDA either: (1) intends to continue working with the applicant to resolve any outstanding deficiencies (no hold), or (2) FDA has identified deficiencies sufficient to place the submission on hold. Substantive Interactions should occur following acceptance of the submission and only after FDA has performed a complete review with targets of within 60 days of receipt of a complete 510(k) or within 90 days of the filing date of an original PMA, Panel-Track PMA Supplement, or 180-Day PMA Supplement.
Continue reading

pills.jpgOn February 13 and 14, 2013, Leerink Swann (“Leerink”) held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference highlights emerging themes and controversies in healthcare, where Leerink’s equity analysts present surveys and moderate discussions with MEDACorp Key Opinion Leaders and industry specialists to provide unique and timely insights. MEDACorp is Leerink’s network of 30,000 healthcare professionals including key opinion leaders, practitioners, clinicians, and hospital administrators. In between the main panels, senior management from some of the companies identified by Leerink as the most prominent and promising deliver “fireside chats” and presentations with company updates, including discussions of new products in their pipeline under review. This year the sole sponsor of Leerink’s Global Healthcare Conference was Latham & Watkins LLP.

Headlining the Conference was a Keynote Address entitled “Innovating Medical Product Development – FDA and Other Forward Looking Trends” delivered by Vicki L. Seyfert-Margolis, Ph.D. Seyfert-Margolis just recently was the Senior Advisor for Science Innovation and Policy in FDA’s Office of the Commissioner. Seyfert-Margolis is currently Chief Science and Strategy Officer for Precision Health, which provides services, infrastructure, and technologies to companies developing personalized medicines.

Seyfert-Margolis worked for about three and a half years in FDA’s Office of the Commissioner, where she led the effort to help develop a more coherent policy for companion diagnostic and personalized medicine, including developing guidances for personalized medicine such as “In Vitro Companion Diagnostic Devices” and “Qualification Process for Drug Development Tools“. While at FDA, Seyfert-Margolis looked at why companies were not seeing as many returns from their investments in research and development, noting that it was not FDA’s “fault” for less new chemical entity filings, because FDA can only review or approve products that are filed in new applications.
Continue reading