Blog

FDA unveils plan to regulate lab-developed tests: The FDA at the end of September 2023 unveiled a proposal to begin regulating laboratory-developed tests as medical devices, with enforcement discretion to be phased out over five years to give LDT manufacturers time to adjust. FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the plan is to require LDT makers to register their tests with the Agency, and the tests will be reviewed based on their risk to patients.

FDA issues guidance on pre-approval plant inspections: The FDA will continue to use “alternative tools” such as remote interactive evaluations to assess compliance with good manufacturing practices in support of new drug, abbreviated new drug and biologics license approval applications, according to draft guidance formalizing the Agency’s inspection strategy. Factors the agency will consider when deciding whether remote or onsite inspection is appropriate include inspection history, product type, and feasibility of in-person inspection.

HungeroTrial’s Antal Solyom highlights the overwhelming amount of re-certification applications, noting that some notified bodies are not even accepting new device applications.

Citing International Trade Commission (ITC) Ban, Apple to halt sale of Apple Watch Series 9, Ultra 2 this week: Say sayonara to this popular wearable as its potential ban may go into office effect starting December 25

If court approved, plaintiffs would be entitled to double what they paid for the blood tests, among other potential financial additions.

Brain Computer Interfaces (BCI) Study Helps Voiceless Woman Communicate: Recently, researchers published a study in Nature reporting that a 68-year-old woman with amyotrophic lateral sclerosis (ALS) — their sole research subject — now has the ability to “talk to text” through two (2) small implants with about 120 electrodes that penetrate her brain and monitor neural activity.

Promising results seen with eye-tracking tool for autism diagnosis: A study found that the EarliPoint Evaluation demonstrated high sensitivity and high specificity in predicting expert autism diagnoses. The eye-tracking technology requires children to watch a 10-minute video as it takes eye movement measurements.

Spousal loss may come with significant health effects: Grief over the loss of a lifelong partner can take a serious emotional and physical toll on the surviving spouse, though health impacts vary from person to person. Sociologist Deborah Carr says social support is the most important resource for navigating grief, and recent research has shown that spousal loss tends to be harder on men and those who are widowed at a younger age. Carr says men may have a more difficult time because many have lost the person who cooks for them and reminds them to take care of their health.

Medtronic is the latest and largest device manufacturer to forecast how drugs such as Ozempic and Wegovy will affect demand for medical devices. With the weight loss drugs already taking a bite out of bariatric procedure volumes, CEO Geoff Martha offered Medtronic’s perspective on the impact for its surgical and diabetes businesses

Applesauce linked to elevated lead levels in children: Fifty-two cases of elevated blood lead levels in children aged 1 to 4 have been reported in 25 states, potentially linked to WanaBana apple cinnamon fruit puree pouches. Following a product recall, the FDA is investigating, and parents are considering legal action as concerns grow over the FDA’s struggles to regulate baby food and protect against heavy metal contamination.