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MedTech News

Bessel launches accelerator program for medtech startups

Bessel and an Alabama tech hub today said they are launching Hatch Powered by Bessel, an accelerator program for medtech startups.

Applications are now open for the 10-week program, which starts in Fairhope, Alabama, this summer.

The accelerator “combines the passion of startup founders, the guidance of seasoned medical device experts, and the burgeoning startup ecosystem and investment in Alabama,” Bessel said in a news release. “… The program aims to equip medtech startups to create sustainable and scalable innovations—breakthroughs that scale—and to give founders the entrepreneurial resource ecosystem they need for long-term success.”

Startups selected for the program will receive a travel stipend, access to events and workshops, and guidance on strategy, fundraising and execution from lifescience industry entrepreneurs who will act as mentors and advisors.

The startups will be offered funding…

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From AI transformers to computer-based reasoning to rethinking drug design: AI pioneers discuss the future

Jensen Huang at GTC

In a packed panel discussion at GTC, moderated by NVIDIA Founder and CEO Jensen Huang, the architects of the groundbreaking transformer model gathered to explore their creation’s potential. The panel featured seven of the eight authors of the seminal “Attention Is All You Need Paper” paper, which introduced transformers – a type of neural network designed to handle sequential data, like text or time series, in a way that allows for much more parallel processing than previous architectures like recurrent neural networks (RNNs). Transformers accomplish this through a mechanism called “attention,” which enables the model to differentially weigh the importance of different parts of the input data.

The transformer architecture powers large language models like GPT-4 and has ignited widespread interest in AI applications across industries including in biology, wher…

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PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial

Medtronic (NYSE: MDT) + announced today that the U.S. Patent and Trademark Office upheld claims around two of its patents in its battle with Axonics (Nasdaq:AXNX).

The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of claims in two of Medtronic’s patents in the latest development in a long-running spat between the two companies. It means the PTAB has now upheld the validity of five of the company’s patents at issue in its lawsuit against Axonics.

Medtronic in November 2019 filed a lawsuit against Axonics alleging patent infringements over sacral neuromodulation (SNM) technologies. Since then, the battle has gone back and forth, with the medtech giant most recently asking the U.S. International Trade Commission (ITC) to block the sales of certain Axonics devices.

Medtronic now wants to ask the federal court in the Central District of California to lift its stay on the lawsui…

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FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program

[Image from the SetPoint Medical website]SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot.

TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week.

With acceptance into TAP, SetPoint can progress the development of its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS).

SetPoint designed its device to use precise vagus nerve stimulation. It activates anti-inflammatory and immune-restorative pathways to treat inflammation-mediated autoimmune conditions.

The SetPoint platform features a miniaturized stimulation device placed on the vagus nerve. Onc…

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Hologic CFO: ‘Mass layoffs are a failure of leadership’

Hologic CFO Karleen Oberton [Photo courtesy of Hologic]Hologic (NYSE: HOLX) + CFO Karleen Oberton had some tough words for ax-dropping executives following recent layoffs in the medtech industry and beyond.

In an interview with the Wall Street Journal, Oberton and Hologic CEO Steve MacMillan — who together rode a wave of “COVID cash” from the company’s diagnostics business during the pandemic — discussed how they kept employment steady even as test sales slowed.

The Hologic’s leadership team formed its “philosophy that mass layoffs are a failure of leadership” even before the pandemic, Oberton said.

With nearly $4.9 billion in annual sales, Hologic is the world’s 26th-largest medical device manufacturer, according to Medical Design & Outsourcing‘s Medtech Big 100 ranking by revenue.

That Medtech Big 100 ranking also tracks employment over time. Hologic repor…

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Flosonics raises $20M for wearable ultrasound patch

The FloPatch wearable ultrasound patch. [Image from Flosonics]Flosonics announced that it raised $20 million in a Series C financing round to support its wearable ultrasound technology.

New Leaf Venture Partners led the round, which had participation from existing investors Arboretum Ventures, Genesys Capital and iGan Partners. As part of the deal, Vijay Lathi of New Leaf will join the board of directors at Flosonics.

Sudbury, Ontario-based Flosonics plans to use the funds to support its FloPatch device. It hopes to accelerate commercial growth, expand indications for use and continue evidence generation. The company wants to address the growing demand for wearable AI-assisted sensors.

FloPatch, a first-in-class wearable Doppler ultrasound technology, provides hemodynamic assessments. Flosonics designed FloPatch to streamline and inform clinical diagnoses regarding fluid resuscitation and management. The wearable ultrasound could help improve patient manage…

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Onward raises $22M to support neurostim tech

The Onward ARC-IM implantable pulse generator and lead. [Image from the Onward website]Onward Medical announced today that it successfully raised $21.8 million (€20 million) in gross proceeds through a private placement.

The company offered more than 4.4 million new ordinary shares at an issue price of $4.89 (€4.50) per share. It completed the offering with participation from institutional investors, certain founders and management and members of the board.

Onward plans to use 45% of the net proceeds to fund R&D activities. That includes the development and regulatory process for its investigational ARC-EX system. ARC-EX nerve stimulation technology aims to restore hand and arm function. Additionally, the company plans to put funds toward its investigational ARC-IM system for improved blood pressure regulation after spinal cord injury.

The company also has the ARC-BCI system that won FDA breakthrough device designation last month. Onward didn’t li…

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J&J’s Abiomed has a Class I Impella recall with 49 deaths related to issue

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind.

Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart.

This recall (a correction and not a product removal) affects a number of Impella pumps in the U.S. That includes Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAsist and Impella LD.

Impella pumps provide short-term support for the ventricles during high-risk catheter-based percutaneous coronary interventions (PCIs). Uses also include for ongoing cardiogenic shock, open-heart surgery or cardiomyopathy. The therapy aims to reduce the work of the heart’s ventricles and support the circulatory system.

Abiomed recalled the left-sided blood pumps in this…

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Elixir Medical wins FDA breakthrough designation for DynamX BTK implant

Elixir Medical’s DynamX [Image courtesy of Elixir Medical] Elixir Medical today announced it received FDA breakthrough device designation for its DynamX BTK system for treating chronic limb-threatening ischemia. The Milpitas, California-based company designed the adaptive implant to treat narrowed or blocked vessels below the knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). Elixir Medical said the DynamX Bioadaptor metallic device supports the vessel during the healing phase, unlocking and uncaging the vessel while providing essential dynamic support to restore vessel function and maintain an open lumen. “The Bioadaptor platform was developed to transform treatment of coronary and peripheral artery disease,” CEO Motasim Sirhan said in a news release. “We appreciate the FDA recognition of our innovation for treating the CLTI population with BTK disease and its potential impact on the patients suffering from vascular disease.” According to the co…
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BD ups domestic syringe production in wake of FDA warnings on syringes made in China

BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China.

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.

Earlier this week, the agency issued warning letters to three companies, including U.S.-based Medline. The letters 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.

In response to the latest developments, President of BD Medication Delivery Solutions, Eric Borin, issued a statement today.

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

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FDA clears self-driving mobile C-arm from Siemens Healthineers

The Ciartic Move mobile C-arm with self-driving capabilities. [Image courtesy of Siemens Healthineers]Siemens Healthineers announced today that the FDA granted clearance for its Ciartic Move mobile C-arm with self-driving capabilities.

Ciartic Move accelerates and standardizes 2D fluoroscopic and 3D cone-beam computed technology (CT) imaging. Working in hospitals and outpatient facilities, it enables consistent automated workflows and reduced imaging time.

Siemens Healthineers designed the system to address the needs of orthopedic, trauma and spine surgery. However, it also has utility in thoracic, vascular, cardiovascular and general surgery, plus urology and interventional pulmonology.

According to a news release, Ciartic Move could address intraoperative imaging challenges caused by staff shortages and overloaded OR teams. A fully motorized C-arm can reduce the time, effort and workforce capacity needed to manually move and position the system. It has up…

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Neuralink says patient used brain chip to play chess online

[Image courtesy of Neuralink]Elon Musk’s Neuralink brain-computer interface (BCI) venture showed the early results from the first patient to receive its brain chip implant.

A nine-minute livestream demonstration on Musk’s “X” social media platform (formerly known as Twitter) showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online.

Arbaugh, a quadriplegic, said he was paralyzed below the shoulders in a diving accident eight years ago. His use of the Neuralink BCI to play chess marks the first public demonstration of the potential of the brain implant in humans.

“I love playing chess,” Arbaugh said on the livestream. “This is something you all have enabled me to do. … It’s all being done with my brain.”

Arbaugh went on to say in the broadcast from Neuralink’s account: “It’s crazy. It’s so cool. I’m so lucky to be a part of thi…

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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…

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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…

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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…
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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&…

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


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…

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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…

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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 and Solectron.

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

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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…

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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…

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