Axonics (NSDQ:AXNX) announced today that it commenced a proposed public offering of common stock worth $150 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, also expects to grant underwriters a 30-day option to purchase up to $22.5 million in additional shares of its common stock, […]
Featured
Avenda Health wins FDA breakthrough nod for AI-based prostate cancer treatment
Avenda Health announced today that it received FDA breakthrough device designation for its AI-based male “lumpectomy” product. Santa Monica. Calif.-based Avenda designed its lumpectomy product to treat prostate cancer in-office while preserving the quality of life through AI and minimally invasive technologies, according to a news release. The Avenda Health focal therapy system spares healthy […]
Think Surgical robot can use Ortho Development implants, FDA says
The FDA has cleared two Ortho Development knee implants for use with a Think Surgical robotic system, the companies announced today. Surgeons will now be able to use Ortho Development’s Balanced Knee system (BKS) and BKS TriMax implants with Think Surgical’s TSolution One total knee arthroplasty system. TSolution One is the only commercially available active robot system for total […]
SmileDirectClub slides on mixed bag Q1
SmileDirectClub (NSDQ:SDC) shares dipped today on first-quarter results that were mixed compared to the consensus forecast. The Nashville, Tenn.-based dental technology company posted losses of $29.9 million, or -25¢ per share, on sales of $188.8 million for the three months ended March 31, 2021, for a -2.3% bottom-line slide on sales growth of 2.6%. Adjusted […]
Shockwave Medical stock up nearly 21%
Shockwave Medical (NSDQ:SWAV) posted first-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates. Shockwave Medical, though, also said it projects revenue for the full year to roughly triple to between $195–205 million — representing 188–202% growth over the prior year’s revenue. The Santa Clara, Calif.-based company — which has proprietary cardiovascular […]
FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents
The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic […]
New ethylene oxide regulations now expected in 2022
The EPA now estimates that it will propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022. The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal. Now the EPA’s inspector general wants the agency to conduct a new residual […]
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release. Get the full story at our sister site, […]
BWXT Medical to make TheraSphere microspheres for Boston Scientific
BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere. Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company. TheraSphere treatment for patients with hepatocellular carcinoma (HCC) delivers millions of glass microspheres containing radioactive […]
MedTech 100 roundup: Largest slide for industry in 2021
The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best and […]
Insulet shares down after Q1 miss
Insulet (NSDQ:PODD) stock is down today — a day after the wearable insulin delivery system developer posted break-even Q1 results that were lower than analysts’ expectations. The company, however, yesterday evening raised the low end of its revenue guidance range to 16–20%. The range was previously 15–20%. The Acton, Mass.-based company a net loss of […]