Korean aesthetic device company Wontech said today it won FDA 510(k) clearance for its Picocare picosecond laser device designed for tattoo removal. The Picocare is a picosecond Nd:YAG based laser designed to remove tattoos in various colors, selectively removing pigment particles to minimize skin tissue damage. “Picocare has received a lot of praise for successfully […]
Food & Drug Administration (FDA)
Implanet wins CE Mark, FDA nod for next-gen Jazz braid
French orthopedic implant company Implanet said today it has won CE Mark approval in the European Union and FDA clearance for its Jazz braid device designed for use with the company’s proprietary Jazz tensioning system. The company said that the new Jazz braid includes improvements based on surgeon feedback it has received since the initial product’s launch […]
7 medtech stories we missed this week: June 23, 2017
From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine […]
FDA approves diagnostic that simultaneously screens for multiple lung cancer types
The FDA said today that it awarded premarket approval to Thermo Fisher Scientific’s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer. The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help […]
Here are the top 5 medtech stories of mid-2017
The middle of 2017 is shaping up to be a continued whirlwind of activity for medtech. FDA is getting used to its new leadership but is facing a continued lack of clarity on user fees and UDIs. Industry is seeing a deeper consolidation in medical supplies, exemplified in Cardinal Health’s purchase of patient recovery supplies from […]
Teleflex says Venture Cath recall is FDA Class I
Teleflex (NYSE:TFX) subsidiary Vascular Solutions today updated on a voluntary recall of its Venture Catheters over issues with excess material on the devices, saying that the FDA labeled it as a Class I recall, it’s most serious designation for recalls. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a […]
FDA grants de novo clearance for Merit Medical’s Embosphere
Merit Medical (NSDQ:MMSI) said yesterday that its Embosphere device won expanded de novo clearance from the to treat benign prostatic hyperplasia. The federal safety watchdog’s clearance means Embosphere can be used in prostatic artery embolization procedures to treat BPH. “Merit’s Embosphere is the first embolic agent to receive FDA 513(f)(2) classification for prostatic artery embolization, providing a non-surgical […]
Bard wins FDA approval for LifeStream covered iliac stent
C.R. Bard (NYSE:BCR) said today that it won pre-market approval from the FDA for its LifeStream covered iliac stent for treating peripheral artery disease. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said. […]
Insulin management software wins FDA nod
Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance. The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower […]
ClearFlow wins FDA 510(k) for FlowGlide
ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains. The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions. “ClearFlow is […]
FDA committee supports Nordisk’s cardiovascular risk claim for Victoza label
Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label. The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk […]