Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA says it acted properly in Medtronic Infuse bone-graft study: Report

The FDA said it acted properly by accepting late patient injury reports from a Medtronic study that showed problems with its Infuse bone graft, adding that the information provided by the devicemaker was "consistent" with data the regulatory agency already had.

FDA gives nod to Hologic, Grifols study to screen U.S. blood supply for Zika virus

The U.S. Food and Drug Administration has given the go-ahead for a trial to use an assay from Hologic and Grifols to test the U.S. blood supply for the Zika virus. The IND study will use the Procleix Zika virus blood screening assay to test donated blood coming from potential endemic areas in the southern U.S.

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.

Biotronik wins CE mark for the first bioresorbable magnesium scaffold for CAD

Biotronik received a CE Mark for its bioresorbable scaffold. The device, intended for the treatment of coronary artery disease without using a permanent implant, is the first clinically proven magnesium scaffold.

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.

Israeli startup BlueWind wins CE Mark for tiny, batteryless overactive bladder neurostimulator

Israeli startup BlueWind Medical has won a CE mark for its miniature wireless neurostimulation device to treat overactive bladder. The first-of-its-kind device is inserted using a minimally invasive procedure and could help improve the quality of life for patients with overactive bladder.

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.

NICE backs use of Boston Scientific laser therapy for outpatient enlarged prostate treatment

Boston Scientific has received positive guidance from the National Institute for Health and Care Excellence (NICE) in support of the use of its GreenLight XPS Laser Therapy System to treat an enlarged prostate. The agency estimated that use of the system could save the U.K.'s National Health Service (NHS) up to £3.2 million annually by enabling an outpatient procedure for benign prostatic hyperplasia (BPH) rather than the traditional surgical resection.  

FDA clears Auris Surgical's robotic endoscopy system

Auris Surgical Robotics has been flying under the radar, billing itself only as a "company based in Silicon Valley." Founded by robotic surgery vet Dr. Frederic Moll, the company has won an FDA clearance for its robotic endoscopy system, which can potentially be used as a diagnostic or surgical tool.

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."