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BioWorld - Tuesday, April 14, 2026
Home » Topics » Cardiovascular, Medical technology

Cardiovascular, Medical technology
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Photo of Scanwatch

It’s time: FDA clears Withings’ Scanwatch with ECG and SpO2 sensors

Oct. 12, 2021
By Annette Boyle
After nearly two years of waiting, Withings SA won FDA clearance for its Scanwatch, a smartwatch that can take an electrocardiogram and monitor for sleep disturbances indicative of sleep apnea or respiratory illnesses such as chronic obstructive pulmonary disease. The FDA action makes the watch the first cleared for both functions.
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Versacross photo

Boston Scientific acquires cardiology business from Baylis for $1.75B

Oct. 6, 2021
By Annette Boyle
Boston Scientific Corp. agreed to acquire the Baylis Medical Company Inc.’s cardiology business, Baylis Medical Co., for an upfront payment of $1.75 billion, subject to closing adjustments. The transaction is expected to close in the first quarter of 2022. Baylis Medical Technologies, which focuses on radiology and neurosurgery, is not part of the deal and will remain a separate entity.
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Selution SLR illustration

Medalliance completes enrollment in drug-eluting balloon trial for treatment of PAD

Oct. 4, 2021
By Bernard Banga
PARIS – M.A. Med Alliance SA (Medalliance), along with its Japanese partner MDK Medical, has completed enrollment following acceptance of a clinical trial notification from the Japanese Pharmaceutical Products and Medical Device Agency (PMDA) in June 2020.
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FDA makes note of differential outcomes in legacy Watchman device

Sep. 27, 2021
By Mark McCarty
The FDA posted an advisory for health care professionals regarding a “potential for differences” between men and women in connection with the use of left atrial appendage (LAA) closure devices. The agency said that differences in procedural outcomes as described in a new medical journal article included a procedure-associated death rate of 0.3% among women undergoing the procedure, triple the rate of 0.1% in men.
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3D illustration of heart cross section

EACH lobbies for comprehensive EU cardiovascular disease policy

Sep. 27, 2021
By Nuala Moran
LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease.
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U.K. flag on stethoscope

NICE says mitral valve-in-valve procedures not ready for routine utilization

Sep. 22, 2021
By Mark McCarty
The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.
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3D illustration of Wolf device in use

Boston Scientific buying Devoro Medical for $269M, continuing its acquisition spree

Sep. 21, 2021
By Annette Boyle
Boston Scientific Corp. grabbed the remaining shares of Devoro Medical Inc. and its Wolf thrombectomy platform in a transaction valued at $269 million. Freemont, Calif.-based Devoro stands to gain an additional $67 million if the company achieves undisclosed clinical and regulatory milestones. Boston Scientific began investing in Devoro in 2019 and currently holds 16% of Devoro. The deal, the Marlborough, Mass.-based company’s fourth major transaction since the start of the second quarter, is expected to close by the end of the year. It follows the acquisitions of Preventice Solutions Inc., of Rochester, Minn., for $1.225 billion in April, which added to the company’s cardiac wearables, and Menlo Park, Calif.-based Farapulse Inc. for $295 million in June, to build out its cardiac ablation position. Boston Scientific purchased Yokneam, Israel-based Lumenis Ltd. for $1.07 billion, in a transaction that just closed three weeks ago.
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Doctor performing surgery

Cardiologist hit with nearly $7M settlement over allegations of unnecessary ablations, stenting

Sep. 20, 2021
By Mark McCarty
Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.
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Flow chart showing how the app works

Cureapp shares results for hypertension digital therapeutic app, seeks regulatory approval and U.S. partner

Sep. 15, 2021
By Gina Lee
Cureapp Inc. is ready to take the next step for its digital therapeutic app (DTA) for hypertension, after completing a late-stage clinical trial and publishing the results. The company said it is the first global trial for a therapeutic app, conducted to seek regulatory approval in the field of hypertension.
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Dollar sign in piggy bank

Nectero Medical nets $19.5M from investors to develop AAA treatment

Sep. 13, 2021
By Catherine Longworth
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a multisite phase I safety study for abdominal aortic aneurysm (AAA) patients and the financing will be used to fund further in vivo and clinical development.
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