Devices
FDA has cleared an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as “grand mal” or “generalized tonic-clonic” seizures. Once detected, the watch sends an alert to summon a caregiver for help. The device measures multiple seizure indicators. It uses “electrodermal activity,” a signal
Drugs
FDA has awarded Octo Consulting a $300 million seven-year contract to meet 21st Century Cures Act requirements to develop a more efficient and streamlined drug and medical device approval process. A company announcement says Octo was chosen by CDER “to support a comprehensive suite of strategic capabilities and processes,
Devices
A 2/5 FDA safety alert warns healthcare providers about reports of venous thromboembolism, including pulmonary embolism (PE), in patients who received autologous immune cell therapy using Therakos, Inc.’s Cellex Photopheresis System. “The onset of these events typically occurred during, or shortly after, active treatment sessions,” the alert says.
Devices
United Health Products has submitted a PMA for HemoStyp for use in internal procedures. The company says it has submitted additional inspection and registration forms to the agency under its Critical-to-Quality pilot program for final approval and confirmation. It says HemoStyp is derived from regenerated oxidized cellulose, and
Devices
Kareway Products has recalled 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, four fluid ounces due to the potential for microbial contamination. “Use of the affected product could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment,” an
Devices
CDRH director Jeff Shuren says that consumers should not be alarmed about findings from a new rodent study evaluating cell phone or radiofrequency energy exposure. In a 2/2 statement, Shuren said “we have not found sufficient evidence that there are adverse health effects in humans caused by exposures at
Devices
Yale University says that a team of its researchers found that FDA’s multi-stage review and alternation process for dermatologic devices has potentially dangerous loopholes. The team reports that many dermatologic devices had been altered after going through the review process, with limited agency inspection. After alteration, it says,
Devices
FDA has granted Grünenthal an expedited access pathway designation for Vivo, a surgical sealant proposed for being an adjunct to standard closure techniques in gastrointestinal procedures to reduce intestinal leakage. The company says the designation recognizes the “high unmet medical need in preventing intestinal leakages after gastrointestinal surgeries — life-threatening
Devices
The Justice Department (DoJ) says the South Dakota federal court accepted 1/31 a guilty plea entered by Robert Lytle to one count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt. The pleas came in
Devices
FDA says that Physicians Products Inc. is selling its Sterile PRP Separation Kit online in violation of the Federal Food, Drug, and Cosmetic Act since it does not have a PMA approval or IDE in effect. “On your Web site, you market the product as ‘FDA approved,’ and offer it
Devices
Masimo has received 510(k) clearance to sell its next-generation SedLine brain function monitoring device for use in anesthetized and sedated patients. The device acquires and processes electroencephalogram (EEG) signals, providing physicians brain function data on anesthetized patients. The revised SedLine “benefits from work to improve the patient state
Devices
A 10/21-11/17/17 FDA inspection at Light Age, Inc., Somerset, NJ, found 12 Quality System Regulation violations in the firm’s manufacturing of Class 2 medical lasers, including EpiCare and Q-Clear. A 1/24 Warning Letter says specific violations listed on an FDA-483 were: * failing
Devices
FDA has issued two final guidances explaining the procedures and criteria the agency intends to use in accepting or refusing a 510(k) or PMA submission. The guidances include checklists to identify the necessary elements and contents of a complete application. FDA says the updates in the documents address provisions
Devices
The Pew Charitable Trusts says HHS should support incorporation of medical device identifiers, particularly implants such as cardiac stents and artificial joints, to claims data as part of efforts to promote healthcare system competition and efficiency. The group’s 1/25 letter says that adding unique device identifiers (UDIs) to
Devices
FDA has cleared a Multi Radiance Medical 510(k) for the MR4 Laser technology for neck and shoulder pain relief. The clearance was based on data from a randomized, double blind, controlled study demonstrating that the device is more effective than placebo for reducing neck and shoulder pain, according to
Drugs
FDA and Duke University’s Center for Health Policy have announced a 4/16 public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The meeting will help the agency develop a guidance on the subject. It will include discussion about various ways in which participation in clinical trials
Drugs
FDA has updated a guidance for Institutional Review Boards and Clinical Investigators to revise its “Payment for Research Subjects: Information Sheet” to clarify that reimbursement for travel expenses to clinical trial sites and associated costs (airfare, parking, and lodging) are acceptable under current practices. The updates were made based on
Devices
FDA has cleared an electroCore 510(k) for an expanded label for gammaCore as an acute treatment of pain associated with migraine in adult patients. The neuromodulation treatment is delivered by a hand-held unit that stimulates the vagus nerve through the skin. It was initially cleared 4/2017 for
Devices
CDRH has posted review metrics for its Accredited Persons Program for 510(k)s. The metrics are mandated by the device user fee program. According to the report, 18 third-party 510(k)s have been reviewed. The average total time from receipt of a 510(k) to a final
Devices
FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the
Drugs
The Justice Department has issued a memorandum outlining factors that department attorneys should consider when determining whether to seek dismissal of a whistleblower (qui tam) suit under the False Claims Act. The document notes there have been record increases in the number of whistleblower suits over the last few years.
Devices
FDA says a finalized guidance issued 12/5/17 modified the agency’s categorization of IDE devices used in clinical investigations. A 1/16 Webinar reviewed the guidance and the rationale for the changes. FDAer Ken Skodacek, who works in the CDRH Clinical Trials Program and in the Payer Communication