Dexcom (NSDQ:DXCM) won CE Mark clearance today in the European Union for its G6 continuous glucose monitoring system. The G6 system, which won approval in the U.S. as ‘fully interoperable’ with other medical devices, includes a redesigned applicator that inserts a small sensor below the user’s skin. The sensor measures glucose levels and sends the data […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
OrthoSensor wins FDA nod for Verasense knee system
OrthoSensor said today it won FDA 510(k) clearance for its Verasense sensor-assisted device designed to be used with Zimmer Biomet‘s (NYSE:ZBH) Persona knee system during total knee replacement procedures. The newly cleared Verasense device uses advanced sensors and wireless connectivity to analyze knee balance and improve outcomes during total knee procedures using the Persona knee system, […]
FDA issues select recall of Draeger Jaundice Meters
The FDA recently posted notice of a select recall of Draeger Medical Jaundice Meters over issues with users misinterpreting the display. The recall affects all Draeger Medical’s Jaundice Meter JM-105 units, and has been labeled as a Class I recall, indicating the potential for serious injury or death. The Draeger Jaundice Meter is designed for […]
LivaNova wins Japanese nod for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease. The London-based company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing […]
FDA clears Edap’s Focal One prostate treatment
Edap (NSDQ:EDAP) said yesterday it won FDA 510(k) clearance for its Focal One device designed for prostate tissue ablation procedures. The French company’s Focal One device uses both magnetic resonance and 3D biopsy data, alongside real-time ultrasound imaging, to allow urologists to view 3D images of the prostate while using high intensity ultrasound to ablate the […]
TransEnterix seeks expanded FDA indications for Senhance platform
TransEnterix (NYSE:TRXC) said yesterday it submitted a 510(k) submission to the FDA seeking clearance for extra instruments for its Senhance robotic surgical platform, including 3 mm diameter instruments. The Research Triangle Park, N.C.-based company said that the clearance would allow the Senhance to be used in microlaparoscopic surgeries. The platform is currently cleared for laparoscopic colorectal, […]
Corindus wins Japanese PMDA clearance for CorPath GRX platform
Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device. The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said. “I look forward to offering CorPath GRX to my patients […]
7 medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia […]
AcelRx tackles acute pain with sublingual drug-delivery tech
While pain medicine specialist Dr. Pamela Palmer was working at the University of California-San Francisco, she noticed something peculiar was happening to patients undergoing surgery – many who survived their procedures were dying of opioid overdoses as a result of patient-controlled drug pumps. “The nurse has to program a number of parameters into it and, […]
FDA labels IABP recall for Getinge’s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed […]
Hospira issues nationwide recall for opioid overdose reversal drug
Pfizer’s Hospira unit this week voluntarily recalled two lots of a drug used to reverse the course of an opioid overdose. The company’s naxolone injection, sold in its Carpuject single-use cartridge syringe, was recalled due to the potential presence of embedded and loose particulate matter in the plunger. Get the full story at our sister site, Drug Delivery […]