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Intuitive Ion wins regulatory approval in China

The Intuitive Ion system [Image from Intuitive]Intuitive Surgical (NASDAQ: ISRG) + has received approval from regulatory authorities in China to market its Ion surgical robot system.

BTIG analyst Ryan Zimmerman said today that the National Medical Products Administration in China approved the system. This occurred through Intuitive’s partnership with Shanghai Fosun Pharmaceutical, a venture established in 2016.

The major regulatory nod in China follows last week’s FDA approval for the company’s next-generation da Vinci 5 surgical robot.

Intuitive Fosun now produces most of the biopsy needles used in the Ion system and has capacity for about 70% of the global demand, Zimmerman says. Zimmerman and BTIG’s Iseult McMahon said in their report that they expect Intuitive to “ramp up Ion production and sales in China rapidly as a result.”

The analysts said that, along with regulat…

Ultrahuman brings in $35M to support wearable health monitoring tech

The Ring Air wearable health monitoring system. [Image courtesy of Ultrahuman]Ultrahuman announced today that it raised $35 million in an equity and debt investment round.

Blume Ventures, Steadview Capital, Nexus Venture Partners, Alpha Wave and Zomato founder Deepinder Goyal participated in the round. Ultrahuman plans to use the funds to build toward further manufacturing capacity and deeper research in the health tracking space.

Ultrahuman develops a smart ring called Ring Air, plus a continuous glucose monitor (CGM) wearable called M1 Live. It also offers a home health device called Ultrahuman Home and a preventive blood testing product called Blood Vision. The company’s platform integrates glucose, sleep, movement, blood markers and HRV for a comprehensive approach to health monitoring.

“This funding round marks a pivotal step forward in our journey to dominate the smart rings space, bringing us closer to our goal of being the market leader&…

Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year

The IQ+ system [Image courtesy of Butterfly Network]Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system.

The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe.

According to a news release, the additional certification allows Butterfly Network to release important new features to all existing and prospective European customers. That includes its pulse wave doppler (PWD) in presets and its AI-enabled auto B-line counter. Butterfly expects to roll out these additional functionalities within the second quarter of 2024.

The new feature release spans Europe, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK. Butterfly iQ+ can…

Bio-Rad names Roop Lakkaraju as CFO

Roop K. Lakkaraju, EVP and CFO of Bio-Rad [Image from LinkedIn]Bio-Rad today announced it appointed Roop K. Lakkaraju as EVP and chief financial officer, effective April 15.

Lakkaraju joins the clinical diagnostics and imaging systems company from Benchmark Electronics where he served as EVP and chief financial officer and was responsible for all finance-related functions since 2018.

“We are pleased to welcome Roop Lakkaraju as our new chief financial officer,” CEO and President Norman Schwartz said in a news release. “Roop’s extensive experience and track record in financial management, operations, mergers and acquisitions, and capital markets transactions will be instrumental in helping us shape and execute our financial strategy.”

Prior to his tenure at Benchmark, Lakkaraju held CFO and senior operational roles at several large, multinational companies, including Support.com and Solectron.

“I am excited to join Bio-Rad as its chief financial offic…

LivaNova reports positive study results for neuromod for sleep apnea

LivaNova (Nasdaq: LIVN) + today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea.

The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint.

London-based LivaNova’s OSPREY trial evaluates its aura6000 hypoglossal nerve stimulator system. It pits the system against a no-stimulation control group in subjects with moderate to severe obstructive sleep apnea (OSA). These patients failed with or are unwilling to use positive airway pressure (PAP) treatment.

Following the milestone, LivaNova said investigators plan to continue long-term follow-ups through the primary endpoint and beyond.

The trial its primary efficacy endpoint as the demonstration that the apnea-hypopnea…

Fujifilm wins FDA nod for AI-powered endoscopy tech that could rival Medtronic’s GI Genius

The Cad Eye AI-powered endoscopy system. [Image courtesy of Fujifilm]Fujifilm announced today that the FDA granted 510(k) clearance for its CAD EYE AI-powered detection system for endoscopic imaging.

CAD EYE enables the real-time detection of colonic mucosal lesions like polyps and adenomas during colonoscopy procedures. It supports endoscopists in detecting and removing pre-cancerous lesions, regardless of size, shape and color. The system enters a market currently cornered by Medtronic and its GI Genius system.

GI Genius, a computer-aided polyp detection system powered by AI, first became available in the U.S. in 2021. Read more about Medtronic’s AI-related efforts for GI Genius here.

Fujifilm’s system features a compatible expansion unit (the Fujifilm EX-1) and endoscopy support software (EW10-EC02). CAD Eye builds upon the company’s Eluxeo endoscopic imaging system, with AI image processing for integration with the system’s proce…

Insulet picks new CFO following McMillan’s move to 3M spinoff

Ana Maria Chadwick [Image courtesy of Insulet]Insulet (Nasdaq: PODD) + announced today that it appointed Ana Maria Chadwick as its new EVP, CFO and treasurer.

Chadwick’s appointment — which goes into effect on April 22, 2024 — follows an extensive search process conducted by Insulet. That search spanned nearly six months after former CFO Wayde McMillan left for 3M’s Solventum healthcare spinoff in October.

Lauren Budden served as interim CFO and treasurer following McMillan’s departure. Insulet plans for her to continue in her role as group VP, chief accounting officer and controller.

Chadwick now joins Acton, Massachusetts-based Insulet, a developer of automated insulin delivery technology, with more than 30 years of experience in propelling growth within organizations.

Get the full story at our sister site, Drug Delivery Business News.

FDA issues warning letter to Medline over plastic syringes from China

The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline.

In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

On March 18, 2024, the FDA issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to three companies: Jiangsu Shenli Medical Production, Medline Industries and Sol-Millenium Medical.

Medline — the fourth-largest medical device company in the world, according to our 2023 Big 100 list — markets and distributes plastic syringes made in China within the U.S.

Get the…

Health Canada licenses Medtronic Symplicity Spyral renal denervation system

The Medtronic Symplicty Spyral RDN system expands inside the renal arteries. It then ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system.

The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated.

Approval in Canada comes about four months after the company’s landmark FDA approval for Symplicity Spyral in November 2023.

Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.

After sedat…

Medtronic is raising the bar on outcomes with MiniMed 780G automated insulin delivery system

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]Not long ago, automated insulin delivery technology from Medtronic (NYSE: MDT) + ranked third in the market in terms of patient satisfaction.

That’s according to the Diabetes Patient Voice survey (DQ&A) — a third-party survey that evaluates U.S. diabetes patient satisfaction on a quarterly basis. However, the patient responses were for the previous-generation MiniMed 670G — before the company brought its next-generation MiniMed 780G system to the market.

The current iteration of MiniMed 780G uses the latest Guardian 4 technology and requires no fingersticks while in “SmartGuard” mode. It provides meal detection technology providing automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

MiniMed 780G with Guardian 4 offers insulin to account…

After Intuitive, Shockwave and Avail, Daniel Hawkins is now CEO at AI-powered MRI software startup Vista.ai

Former Avail Medsystems CEO Daniel Hawkins is now president and CEO of Vista.ai. [Photo courtesy of Avail Medsystems]Avail Medsystems founder and former CEO Daniel Hawkins has a new job as president and CEO of MRI software startup Vista.ai.

Palo Alto, California-based Vista.ai (founded and incorporated as HeartVista) makes AI-guided software for automating magnetic resonance imaging (MRI) exams.

Vista.ai was founded by Chief Medical Officer Bob Hu, Chief Architect and Head of Research Juan Santos and Chief Technology Officer William Overall. Its advisory board includes Stanford University doctors and professors and the radiology chair at the University of Wisconsin–Madison.

The company won FDA 510(k) clearances for its HeartVista Workstation with RTHawk application software for the acquisition of real-time and accelerated images from GE Healthcare whole-body MRI systems in 2014, 2017 and 2017. In 2019, the FDA cleared the company’s AI-assisted One Cli…

Biden signs executive order for women’s health research and innovation

President Joe Biden [Image courtesy of the White House]President Joe Biden this week signed an executive order that will direct funds and actions toward expanding and improving research on women’s health.

The initiative builds on First Lady Jill Biden’s announcement last month in which the Advanced Research Projects Agency for Health (ARPA-H) earmarked $100 million in funds to “fundamentally change” how the U.S. approaches and funds women’s health research.

This week’s executive order follows President Biden’s March 7 State of the Union address, in which he called on Congress to invest $12 billion in new funding for women’s health research.

Biden’s executive order will create directives that will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, according to the White House. It will also motivate new research on a wide range of topics in womenR…