Boston Scientific (NYSE:BSX) today said it received FDA 510(k) clearance for its Lux-Dx Insertable Cardiac Monitor System. The system is a long-term diagnostic device that is implanted into patients to detect arrhythmias associated with atrial fibrillation, cryptogenic stroke and syncope. Lux-Dx is designed with a dual-stage algorithm that can detect and verify potential arrhythmias before sending […]
Boston Scientific touts SpaceOAR meta-analysis results
Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
CMS moves to boost access to Boston Sci’s single-use duodenoscope
Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope. The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide […]
The George Floyd case has rocked a major U.S. medtech hub: Here’s what industry leaders think
Major medtech companies with a presence in the Minnesota and elsewhere have been calling for peace, unity and racial justice following the death of George Floyd in police custody and the resulting demonstrations and violence. Executives from Boston Scientific, Medtronic and the Medical Alley Association have penned open letters expressing their concerns and pledging to […]
U of M releases Coventor ventilator design as open-source
The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source. Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA […]
MedTech 100 roundup: Stocks peak to end May
Medtech stocks closed May at their highest point since before the COVID-19 pandemic rocked the markets. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.17 points at the end of last week (May 29). That total represents a 2.3% gain from the 85.22-point total at the […]
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local impedance — electrical resistance — around the tip of […]
Boston Scientific execs address George Floyd’s death in Minneapolis
Boston Scientific (NYSE:BSX) executives today urged U.S. employees to talk, listen and take action against racism and violence, citing Monday’s death of a black man while in police custody in Minneapolis. George Floyd, 46, died while a Minneapolis police officer pressed his knee on Floyd’s neck and bystanders pleaded for the officer to stop. One witness’s […]
Boston Scientific raises $2b in concurrent stock offerings
Boston Scientific (NYSE:BSX) announced that it completed concurrent offerings of common stock and preferred stock totaling nearly $2 billion. One offering included nearly 29.4 million shares of common stock with an option to purchase up to 3.8 million more shares priced at $34.25 per share. The other consisted of almost 10.1 million shares of 5.5% mandatory […]
Boston Scientific lists concurrent $750m offerings
Boston Scientific (NYSE:BSX) announced that it commenced concurrent offerings of common stock and preferred stock, each totaling $750 million. The Marlborough, Mass.-based company is offering $750 million shares of common stock and $750 shares of Series A mandatory convertible preferred stock. It also expects to grant underwriters separate 30-day options to purchase up to an additional […]
- 1
- 2
- 3
- …
- 146
- Next Page »
