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FDA

Latest Headlines

Latest Headlines

Canadian micro-cap starts PMA submission for novel sepsis device

The FDA has accepted one of two preclinical modules from its PMA application for Toraymyxin from Spectral Medical, the company said. This news comes soon after Spectral snagged a solid CA$10 million (US$7.1 million) in funding this past January, specifically aimed at helping the company finalize its PMA submission for FDA approval.

NEA, JJDC-backed startup raises $46M+ to get heart failure device through Expedited Access Pathway

CVRx has raised $46.5 million a little more than 6 months after it received Expedited Access Pathway Designation from the FDA for its heart failure neuromodulation implant tech. The designation was gained because its Barostim Therapy is intended to treat heart failure patients who have no other treatment alternative.

FDA approves novel stomach-emptying device to treat obesity

The FDA has added a fourth kind of obesity treatment device to its roster of approved interventions. The agency has approved the AspireAssist System from Pennsylvania-based startup Aspire Bariatrics. The device works to drain part of the stomach contents after each meal via a surgically place tube.

Proposed U.S. bill would require docs to report medical device adverse events to the FDA

The Medical Device Guardians Act would require physicians and physicians' offices to report "adverse events" that occur when a medical device is in use and would also consider those individuals and institutions "protected."

Aussie micro cap AirXpanders raises $15M to prep for anticipated U.S. launch in 1Q17

Australian device company AirXpanders has raised AU$20 million (US$15 million) in a private placement in anticipation of an FDA clearance--and subsequent U.S. launch in the first quarter of 2017--for its novel tissue expansion tech for women undergoing breast reconstruction after mastectomy.

Fitbit hints at FDA regulation, as it launches corporate wellness, population health biz

Corporate wellness--and broader population health initiatives along those lines--is a small part of Fitbit's business right now. But the dominant wearable player is preparing to become a powerhouse tapping into the massive markets generated by major employers and insurers.

Roche scores first liquid biopsy FDA approval with Tarceva companion Dx

Liquid biopsy offers the promise of more accurate, and potentially earlier, cancer diagnoses based on the genetic analysis of circulating tumor cells in the blood. While a lot of money and strategic interest is already chasing the notion of the liquid biopsy, now the FDA has signed off on the idea for the first time with an approval for a companion diagnostic for the oncology drug Tarceva.

FDA accepts 17, rejects 12 in first year of medical device Expedited Access Pathway

The FDA has made 29 decisions under its new Expedited Access Pathway Program for Medical Devices in its first year, the agency noted in a recent blog post. Of these, 17 were accepted with the remainder denied. These decisions were usually made in 30 days.

Roche to sell Senseonics implantable glucose sensor system in some EU countries

Roche's Diabetes Care has signed a deal with implantable glucose sensor company Senseonics to sell its Eversense Continuous Glucose Monitoring System in Germany, Italy and the Netherlands. The deal comes just after a CE mark for the system earlier this month.

FDA approved high-risk women's health devices without proper data: Study

Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.