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BioWorld - Wednesday, March 4, 2026
Home » Authors » Annette Boyle

Articles by Annette Boyle

MIRA Virtual Incision

Virtual Incision’s miniature robotic surgery device gets FDA nod

Feb. 26, 2024
By Annette Boyle
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
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Zimmer Biomet Rosa shoulder

Zimmer Biomet wins new FDA clearance of Rosa robotic shoulder system

Feb. 23, 2024
By Annette Boyle
Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.
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Financial line graph

Cagent Vascular sweeps in $30M series C

Feb. 22, 2024
By Annette Boyle
Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).
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Blue heart and data grid

Reprieve emerges from stealth with $42M for heart failure treatment

Feb. 21, 2024
By Annette Boyle
Reprieve Cardiovascular Inc. landed $42 million in its first fundraising round out of stealth to fund development of its acute decompensated heart failure treatment. The series A round will support clinical and development programs, including the ongoing FASTR trial and Reprieve’s upcoming pivotal trial.
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AspyreRx

Looking Better: Digital therapy reduces liver fat in 90 days

Feb. 20, 2024
By Annette Boyle
Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
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Adagio

Adagio speeds up financing rhythm with $42M SPAC deal

Feb. 16, 2024
By Annette Boyle
The slow pace of financing in med-tech appears to have stimulated cardiac arrhythmia technology developer Adagio Medical Inc. to turn to a special purpose acquisition company (SPAC) in a type of deal that has all but vanished in the last year. The company signed an agreement with Arya Sciences Acquisition Corp. IV to combine in a reverse merger deal that will result in Adagio’s listing on Nasdaq under “ADGM.”
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Freenome co-founder Riley Ennis

Freenome liberated with $254M infusion for cancer testing

Feb. 15, 2024
By Annette Boyle
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”
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4-9-Abbott-Triclip.png

FDA advisory committee gives Abbott a valentine with Triclip endorsement

Feb. 14, 2024
By Annette Boyle
Just in time for Valentine’s Day, the circulatory system devices panel of the medical devices advisory committee for the U.S. FDA showed some love for Abbott Laboratories’ Triclip transcatheter edge-to edge repair (TEER) system for leaky tricuspid heart valves.
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Masimo MightySat pulse ox

FDA hands Masimo first clearance for medical-grade OTC pulse ox

Feb. 13, 2024
By Annette Boyle
Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.
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IlluminOss Medical ABL light fiber

Illuminoss blue-light special gains new clearance, shows antimicrobial efficacy

Feb. 12, 2024
By Annette Boyle
It’s been a good month for Illuminoss Medical Inc. In less than three weeks, the East Providence, R.I.-based company received U.S. FDA clearance of its new light-emitting diode (LED) console, achieved the 10,000th use of its bone-strengthening technology and presented promising results of research on use of its signature blue light for antimicrobial applications.
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