Hologic (NSDQ:HOLX) said today it won expanded FDA 510(k) clearance for its subsidiary Cynosure’s SculpSure non-invasive body contouring laser, now cleared to treat the submental area. The new treatment indication expands the total for the company to 6, as the device is already cleared to treat the abdomen, flanks, back, inner and outer thighs, the Marlborough, […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Medtrobotics submits FDA application for transabdominal robotic scope
Medrobotics said today it submitted an application to the FDA as it seeks clearance for a flexible transabdominal robotic scope designed to visualize anatomy in the thoracic and abdominal cavities. The Raynham, Mass.-based company produces the Flex robot-assisted surgery platform, which is designed for transoral, colorectal and other minimally invasive procedures. The company touts the […]
4 top medtech stories you need to know in late 2017
The U.S. government continues to create a lot of uncertainty for the medical device industry, but medtech companies are still making some big moves. The frenzy of major mergers continues, which makes sense from an investor standpoint when it comes to reducing risk. Meanwhile, companies from outside the industry – including such high-tech giants as Apple, […]
SteadyMed requests meeting with FDA over rejected application for drug-device combo
Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the FDA in June, […]
FDA deals setback to Intarcia for diabetes implant
Privately-held biopharma Intarcia Therapeutics revealed today that the FDA rejected its exenatide implant, ITCA 650, designed to treat Type II diabetes. The company said that it doesn’t think it will need to conduct new pivotal trials in order to address the concerns brought about by the FDA’s complete response letter. Get the full story at our sister […]
India’s NPPA tells Boston Scientific to choose between exiting stent market or seeking higher price caps
India’s National Pharmaceutical Pricing Authority has told Boston Scientific (NYSE:BSX) it has to choose between either seeking to withdraw its premium coronary stents from the market or seeking a higher price for them after the Authority received applications for both options, according to an Indian Economic Times report. The company was blocked from removing its Promus […]
Medtronic wins expanded FDA nod for HeartWare HVAD as destination therapy
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its HeartWare HVAD system, now cleared as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HeartWare HVAD system is a left ventricular assist device designed to aid the heart and increase the amount of blood pumped through the […]
FDA approves first glucose sensing tech that doesn’t require routine finger sticks
Abbott (NYSE:ABT) said yesterday that the FDA approved its FreeStyle Libre Flash glucose monitoring system as a replacement for blood glucose monitoring for adults with diabetes. The company’s technology doesn’t require finger stick calibration and eliminates the need for users to routinely stick their fingers for samples. Get the full story at our sister site, Drug […]
LivaNova, Microport win approval for Rega pacemakers in China
LivaNova (NSDQ:LIVN) and MicroPort Scientific (HKG:0853) said today that the group’s joint venture, MicroPort Sorin Cardiac Rhythm Management Co., won approval for its family of Rega pacemakers in China. The Rega devices are the first domestically manufactured pacemakers that meet international standards in China, the companies touted. The pacemakers are the smallest on the Chinese cardiac […]
TVA Medical wins CE Mark for EverlinQ 4 endoAVF
TVA Medical said today it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach. The Austin, Texas-based company said the system consists of 2 magnetic catheters which are inserted into an artery and vein in the arm and use a small […]
CardioFocus lands CE Mark for next-gen atrial fibrillation balloon
CardioFocus said today that it won CE Mark approval for its HeartLight Excalibur balloon, designed for the treatment of atrial fibrillation. The Marlborough, Mass.-based company’s device combines the HeartLight endoscopic ablation system with features that optimize the speed and magnitude of target tissue contact during pulmonary vein isolation procedures, according to CardioFocus. The Excalibur balloon […]