Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]
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Pharma 50: Here’s how the world’s largest pharma companies are doing
The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data […]
Medtronic HeartWare instructions recall is serious
Medtronic (NYSE:MDT) is recalling its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. FDA today designated the recall as Class I, its most serious level of recall. The HeartWare ventricular assist device (HVAD) is used as a bridge to heart transplants in […]
Asensus Surgical posts Q1 earnings beat
Asensus Surgical (NYSE:ASXC) shares are down today — a day after the company posted Q1 results that edged the consensus earnings forecast. The Research Triangle Park, N.C.-based robotic surgery company — formerly known as TransEnterix — posted losses of -$17.3 million, or -8¢ per share, on sales of $2.1 million for the three months ended […]
How PhysIQ is advancing digital therapeutics through its partnership with Janssen
A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform. Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, […]
Axonics announces $150M offering
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, […]
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 […]