Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves first standalone 3-D mammography system for Siemens

The use of 3-D mammography to complement a standard 2-D approach in breast cancer screening is becoming more standard. But all previous FDA approvals of mammography systems have included a combination of both 3-D and 2-D approaches. Now, Siemens has nabbed the first FDA approval for a 3-D digital breast tomosynthesis system.

Medtronic buys into power morcellators in $350M purchase from Smith & Nephew

Medtronic is buying up the gynecology business from Smith & Nephew for about $350 million. The move is particularly interesting since the purchase is focused on the Truclear power morcellation system.

Allergan nabs positive pivotal results from $125M+ Oculeve buy; to submit to FDA next half

Two pivotal trials of the Oculeve Intranasal Tear Neurostimulator both met their primary and secondary efficacy endpoints.

Startup slated to launch injectable, one-year tissue oxygen sensor this year in EU

Profusa snagged more than $13 million in venture backing and added a Google VC to its board late last year. Now, it's readying to debut its first product: the Lumee Oxygen Sensing System. The injectable biosensor measures dissolved oxygen in the tissue.

Heart failure device startup nabs $30M led by Hong Kong property developer's fund

Impulse Dynamics has grabbed a $30 million cash infusion as it nears data from a pivotal U.S. trial for its chronic heart failure device. It's already marketed in Europe and been implanted in more than 3,000 patients.

GERD neurostim startup nabs $25M to back ex-U.S. sales, conduct U.S. pivotal trial

Gastroesophageal reflux disease (GERD) is a common indication that's poorly served by existing drug therapies. Now Dutch startup EndoStim has gotten a $25 million Series D infusion to market its neurostimulation device to treat GERD outside the U.S. and to start a pivotal trial within it to gain FDA approval.

Senseonics nabs CE Mark for implantable glucose monitor, as it readies for FDA next half

Senseonics has a novel approach to blood glucose monitoring with its subcutaneous implant system. And now it's got a CE mark approval for it and is gearing up for an FDA submission.

Urine trumps blood for Zika testing, CDC says

When it comes to Zika testing, urine is better than blood, according to new guidelines issued by the Centers for Disease Control and Prevention. The CDC recently updated its interim diagnostic testing guidance for the virus to recommend real-time reverse transcription-polymerase chain reaction testing for urine specimens obtained two weeks after the illness starts.

TransEnterix falls further as it ditches FDA-blocked surgical robot to focus on another

Investors are looking to place a bet on surgical robotics companies that can follow in the massive footprints of Intuitive Surgical. That company has long stood alone in the promising, but often treacherous field. Micro cap TransEnterix saw some of that Wall Street support earlier this year in advance of an expected clearance for the company's SurgiBot system.  

FDA rolls out draft guidance for 3-D printed medical devices

The FDA has unveiled new draft guidance for 3-D printing, laying out its thoughts on the technology and device regulation as more med tech companies jump into the fast-growing field.