Tandem Diabetes Care (NSDQ:TNDM) shareholders have approved a 1-for-10 reverse stock split, the company said earlier this week, which took effect today. In a statement filed with the SEC in July, the San Diego, Calif.-based company told shareholders that it believed a reverse stock split would help Tandem keep its common stock listed on the Nasdaq […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medtronic wins expanded FDA nod for Endurant II stent graft
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies. Prior to receiving the clearance, patients with short infra-renal necks were classified […]
India pulls an about-face on Abbott’s Xience Alpine stent
India’s Department of Pharmaceuticals has stopped Abbott (NYSE:ABT) from pulling its Xience Alpine drug-eluting coronary stent from the market. The move is a reversal from the National Pharmaceutical Pricing Authority’s decision last month to allow Abbott to withdraw the device over a one-year period. Get the full story at our sister site, Drug Delivery Business News.
IntelliJoint Surgical wins CE Mark for Hip 3D hip arthroplasty nav system
IntelliJoint Surgical said this week it won CE Mark approval in the European Union for its IntelliJoint Hip 3D mini-optical navigation system. The Waterloo, Ontario-based company said the system is designed to provide surgeons with measurements for cup position, leg length and offset for total hip arthroplasty procedures without requiring pre-operative or intra-operative imaging. The Hip […]
7 medtech stories we missed this week: Oct. 6, 2017
From Intellijoint’s CE Mark to Patrona Medical and Kopis’ new partnership, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intellijoint CE Mark for flagship hip navigation Intellijoint surgical announced in an Oct. 4 press release that it has received CE Mark for its Intellijoint HIP System in […]
Appeals court revives Thoratec shareholders suit
A Ninth Circuit panel this week revived a shareholders suit against Thoratec (NSDQ:THOR), deciding that it was a mistake for a lower court to dismiss the case and that investors had sufficient grounds for claiming that the company misled them. The securities class action suit was brought against Thoratec in January 2014. Investor Bradley Cooper sued the […]
FDA issues new user fee guidances
The FDA has released seven new, or updated, guidance documents relating to its user fee programs and performance goals outlined in the fourth version of the Medical Device User Fee Amendments. In MDUFA IV, FDA agreed to accelerate approval decisions for most medical device submissions. In exchange, user fees were bumped up and a new […]
FDA approves new trial for Nellix stent graft from Endologix
Endologix (NSDQ:ELGX) said today that it won an investigational device exemption from the FDA for a clinical trial of its star-crossed Nellix stent graft, after the federal safety watchdog earlier this year asked for two-year follow-up data on the device. CEO John McDermott said the IDE approval sets the stage for a possible pre-market approval in […]
First test to screen blood donations for Zika virus wins FDA nod
The FDA today approved Roche Molecular System‘s (OTC:RHHBY) cobas Zika test, which detects Zika virus RNA in plasma specimens collected from volunteer blood donors and living organ donors. The test is designed to be used by blood collection establishments to detect Zika virus in blood donations – not for the diagnosis of Zika virus infection in […]
FDA clears Peerbridge Health’s Cor wireless ECG monitor
Health information technology company Peerbridge Health said this week it won FDA 510(k) clearance for its Peerbridge Cor wireless electrocardiogram monitor. The New York-based company claims the Cor has the smallest on-body footprint of any wearable monitor and provides multiple channels of ECG through water-resistant electrodes to enable continuous monitoring. Data from a clinical trial […]
Who got picked for FDA’s digital health pre-cert pilot?
FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the AdvaMed MedTech […]