Sean Whooley

Brookline, Massachusetts

Assistant Editor, Life Sciences at MassDevice

Assistant Editor, Life Sciences at Drug Discovery & Development

Assistant Editor, Life Sciences at Medical Tubing + Extrusion

Assistant Editor, Life Sciences at WTWH Media LLC

Assistant Editor at @MassDevice/@WTWH_Media

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Articles

Conavi warns on intravascular catheter issue

6 days ago | massdevice.com | Sean Whooley

The FDA today issued an alert related to a potentially high-risk device issue with certain Conavi Novasight Hybrid catheters. Its communication comes as part of its pilot to enhance the medical device recall program. The FDA said it became aware of the issue after Conavi sent a letter to affected customers recommending the removal of certain catheters. The communication relates to the Novasight Hybrid catheter (TA-06-0001). Affected lot numbers include 230902, 240202, 240302, 240402 and 240502.
Tidepool has new certification for open-source quality management

6 days ago | drugdeliverybusiness.com | Sean Whooley

Tidepool announced today that it secured a new certification for its open-source quality management system, known as qmsOS. Palo Alto, California-based Tidepool, a non-profit diabetes data management group, develops open-source technology for the diabetes community. That includes the FDA-cleared Tidepool Loop, a “do-it-yourself” (DIY) automated insulin delivery (AID) system. Recent collaborations include integrations with Abbott and Sequel Med Tech, among others.
Sanoculis wins CE mark for minimally invasive glaucoma treatment

6 days ago | massdevice.com | Sean Whooley

Sanoculis announced that it received CE mark for its MINT (minimally invasive nasal trabeculostomy) product. MINT, a stent-free platform, helps treat adult patients undergoing glaucoma angle surgery. The system utilizes a unique mechanical, semi-automated trephination technology. Its cutting-edge diameter of 0.14 mm creates precise openings in the pigmented trabecular meshwork.
BVI Medical wins FDA nod for laser endoscopy ophthalmic system

6 days ago | massdevice.com | Sean Whooley

BVI Medical announced that it received FDA 510(k) clearance for its Leos (laser endoscopy ophthalmic system) for treating glaucoma. Waltham, Massachusetts-based BVI designed Leos for a more intuitive laser endoscopic cyclophotocoagulation (ECP) procedure. It aims to integrate seamlessly into the surgical workflow while treating glaucoma.
Edwards touts 8-year data for Resilia valve tissue

6 days ago | massdevice.com | Sean Whooley

Edwards Lifesciences (NYSE: EW) today announced eight-year data highlighting positive long-term outcomes with its proprietary Resilia tissue. Irvine, California-based Edwards — a leader in heart valve technology — designed its Resilia technology to extend valve durability. It utilizes bovine pericardial tissue treated with anti-calcification technology, to serve as the platform for Edwards’ new class of valves.
Imricor kicks off first-in-human ventricular ablation trial

6 days ago | massdevice.com | Sean Whooley

Imricor Medical Systems announced that it commenced a trial by completing its first-in-human ventricular ablation procedure. Guided by real-time MRI through the company’s NorthStar Mapping System, the case took place at Amsterdam University Medical Centre. Imricor says the procedure marked several world firsts, including the first ventricular ablation guided by real-time MRI. It also marked the first left-sided ablation performed under real-time MRI guidance, according to a news release.
Think Surgical has first surgical robot cases with Maxx Orthopedics total knee implant

1 week ago | massdevice.com | Sean Whooley

Think Surgical announced the first successful use of the Maxx Orthopedics Freedom Total Knee implant using its TMINI surgical robot. Dr. David V. Cashen, a joint replacement specialist, performed the first case at Coastal Orthopedics Surgery Center in Bradenton, Florida. Maxx Orthopedics develops the Freedom Total and Titan Knee systems with modern implant design philosophies and multiple bearing surfaces. They meet the demands of a diverse patient population, according to a news release.
BCI company Paradromics names new chief medical officer

1 week ago | massdevice.com | Sean Whooley

Paradromics announced today that it appointed Dr. Stephen Ryu as its new chief medical officer (CMO). The brain-computer interface (BCI) developer said the new appointment will help shape the clinical strategy its advanced neurotech platform. Ryu, a board-certified neurosurgeon, serves as chair of neurosurgery at the Palo Alto Medical Foundation. He holds adjunct professorships in electrical engineering and neurosurgery at Stanford University as well.
Solo Pace wins FDA clearance for temporary pacing during TAVR

1 week ago | massdevice.com | Sean Whooley

Solo Pace announced today that it received FDA clearance for its SoloPace Control System for temporary pacing in TAVR procedures. Along with FDA clearance, the company announced the first-in-human use of the system in a transcatheter aortic valve replacement (TAVR). Designed with standardized workflows, the system improves TAVR temporary pacing efficiency and reduces patient risks. Dr. Paul Teirstein and Dr. Curtiss Stinis completed the initial cases this month at Scripps Clinic.
Adagio Medical wins FDA breakthrough nod for cryoablation tech

1 week ago | massdevice.com | Sean Whooley

Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system. The Laguna Hills, California-based company based its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) ablations, comprising part of the Adagio VT cryoablation system.