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Stryker completes acquisition of SERF SAS

Stryker (NYSE: SYK) + announced today that it completed its previously announced acquisition of joint replacement company SERF SAS.

In December, the Kalamazoo, Michigan-based orthopedic giant struck a deal to buy the France-based company from Menix.

SERF SAS develops, manufactures and sells a range of large joint replacement products on an international basis. This includes inventing the original Dual Mobility Cup for hip replacement. SERF SAS has its main office in Décines-Charpieu, France.

“The acquisition of SERF SAS further strengthens our global portfolio and reinforces our dedication to orthopaedic excellence,” said Katherine Truppi, president of Stryker’s Joint Replacement division. “We welcome the SERF SAS team to Stryker and look forward to working together to help advance product innovation and customer satisfaction.”

SERF SAS complements Stryker’s existing pr…

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…

Creating chemical diversity with flow chemistry

[Orb Pilot Scale up Reactor: Image from Syrris]

Flow chemistry techniques are increasingly being used in drug discovery to provide cost-effective access to a wide range of structurally diverse small molecule analogs, as well as access to previously underused or inaccessible chemistries. There are several ways that this powerful technique can be used to increase structural diversity when building candidate molecules, including linear progression from diverse starting materials, multicomponent reactions around core structural motifs, synthesis of uncommon low diversity starting material sub-sets, and convergent synthesis approaches. The diversity of the starting components is a key consideration when deciding the most suitable strategy for each specific application, but the development of automated, modular flow chemistry systems has made all these approaches far easier to achieve. Here we outline the various methods and…

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&…

Genentech’s lab in the loop aims to tap the power of quantity for quality drug discovery

[NVIDIA]

We can design chips that power self-driving cars and create physically-realistic video footage based on text descriptions. Yet, as Genentech’s Aviv Regev pointed out in a session about the company’s lab in the loop at NVIDIA’s GTC conference, the humble cells within us operate with a complexity that still eludes our full understanding.

It turns out that a cell is itself like a computational device with circuits and code, Regev said. These molecular “circuits” interact with each other, receive information, make decisions, and execute them. “These molecular circuits — they’re hard to reverse engineer,” she said. That hasn’t stopped scientists from spending decades trying to model and predict their behavior. “Mostly unsuccessfully, I can tell you,” Regev added.

But what if we could harness the same technological power driving those other breakthroughs to unravel t…

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.

NVIDIA exec on how ‘NIMs’ can help biopharma navigate the challenges of deploying generative AI

[Image courtesy of Nvidia]

The buzz surrounding generative AI may be undeniable, but its real-world impact on heavily-regulated sectors like drug discovery continues to evolve. Consequently, most drug candidates, circa 90%, continue to fail. Kimberly Powell, vice president of Healthcare at NVIDIA, believes that a new microservices-based offering known as NIMs (NVIDIA Inference Microservices) could help pharma firms navigate this maze. “NIMs were built for the healthcare space, which has very private data,” Powell explained. Healthcare companies, including drug developers, “don’t always want to go to a cloud service. They want to do it in their own environment. We want to give them that capability,” she added.

To date, NVIDIA is offering about two dozen new healthcare microservices with more to follow.

NIMs intend to help scale AI deployment across infrastructures

NIMs, which …

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…