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FDA grants IDE for ZimVie Mobi-C hybrid arthroplasty, fusion study

The Mobi-C cervical disc. [Image courtesy of ZimVie]ZimVie (Nasdaq: ZIMV) + announced today that it received FDA investigational device exemption (IDE) to conduct a study of its Mobi-C.

The study evaluates the Mobi-C cervical disc in hybrid use. Patients in the study receive simultaneous cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) at adjacent levels between C3 and C7. ZimVie says the hybrid construct — where disc replacement and fusion occur in one surgery — can represent the best two-level treatment. The company says it provides a clinical benefit to patients and surgeons, plus economic benefit to stakeholders.

Mobi-C initially received FDA approval for one and two levels in 2013. Surgeons have implanted more than 200,000 Mobi-C implants for cervical disc replacement since 2004. Westminster, Colorado-based ZimVie says it remains the market-leading device for cervical disc replaceme…

Exo unveils new handheld ultrasound device

[Image courtesy of Exo]Exo today unveiled its Iris handheld ultrasound device for versatile imaging performance in point-of-care ultrasound (POCUS).

Santa Clara, California-based Exo said Iris delivers high-performance medical imaging at a fraction of the size and cost of cart-based ultrasound. The system, built on Exo’s advanced silicon technology, fits in the pockets of caregivers. It enables immediate answers at the point of care for physicians, nurses, EMTs and clinicians in emergency, acute care, outpatient and home settings.

Iris blends a simple user experience with powerful, real-time AI to provide instant answers at users’ fingertips. Exo’s patented SweepAI technology automatically acquires images with a sweep of the caregiver’s risk. The company says this reduces operator dependence and bias, ensuring consistent and accurate imaging.

Exo said it equipped Iris with its Bladder AI solution to help caregivers determine bladder …

iRhythm launches next-gen Zio monitor, enhanced long-term monitoring service

The next-generation Zio patch. [Image courtesy of iRhythm Technologies]iRhythm Technologies (Nasdaq: IRTC) + announced today that launched its next-generation Zio monitor in the U.S.

In the launch, San Francisco-based iRhythm also included an enhanced Zio long-term continuous monitoring (LTCM) service.

Zio, the company’s smallest, lightest and thinnest cardiac monitor, aims to enhance the cardiac monitoring experience for patients. The company said its new service enhancements also benefit healthcare providers.

iRhythm says it began shipping already and expects widespread availability across the U.S. by early 2024.

The Zio LTCM service features the Zio patch ECG monitoring device and the Zeus (Zio ECG utilization software) system. Zeus, iRhythm’s advanced AI algorithm, supports the capture and analysis of ECG data recorded by Zio monitor. With the patch and software, the platform also offers a co…

Fast Five: Enovis makes a $840M acquisition, Vicarious Surgical faces NYSE delisting

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, September 26, 2023.

Fast Five by MassDevice · Enovis makes a $840M acquisition, Vicarious Surgical faces NYSE delisting

A new study has backed Attune Medical’s esophagus-protecting device. Fast Five hosts Sean Whooley and Danielle Kirsh explain the technology and the regulatory backing behind it. Read more here>>

Surgical robotics are in the news again. USMI is set to debut its Canady surgical robot. Find out what the robot does and what executives are saying. Read more here>>

Dexcom has signed a partnership with RxFood to focus on AI-based nutrition and glucose monitoring for diabetes management. Whooley explains the goal behind the partnership and how they plan to accomplish their goal. Read more here>>

Vicarious Surgical is facing a…

MMI surgical robot surpasses 500 clinical cases

[Image from Medical Microinstruments]Medical Microinstruments (MMI) today announced the successful completion of more than 500 in-human surgeries with its surgical robot.

The Symani system aims to address the challenges of microsurgery with its NanoWrist instruments. These instruments help to access and suture small, delicate anatomies. That includes veins, arteries, nerves and lymphatic vessels as small as 0.3mm in diameter. It provides motion scaling and tremor reduction to allow precise micro-movements.

Pisa, Italy-based MMI’s Symani received CE mark in 2019, and the company continues to work on U.S. commercialization. The first-of-its-kind robotic technology enables expanded adoptions for patients in need of sot tissue open surgical procedures.

Now, since its first-in-human cases in October 2020, Symani surpasses the 500-procedure milestone. MMI says it rapidly increases patient access to surgical treatment options as surgeons become more comforta…

Study backs esophagus-protecting device from Attune Medical

A rendering of EnsoETM in use. [Image courtesy of Attune Medical]Attune Medical today announced positive data supporting the use of its ensoETM proactive esophageal cooling device.

Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures.

ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago. The FDA granted the device de novo clearance earlier this month for use in RF ablation procedures.

The study, published in the Journal of the American College of Cardiology: Clinical Electrophysiology (JACC-EP), compared ensoETM to luminal esophageal temperature monitoring. It found a significant reduction in the rate of atrioesophageal fistulas (AEFs) during cardiac ablation of the left atrium when using ensoETM. AEF, the most severe form of esophageal injury that occurs during ablation proced…

Enovis to acquire LimaCorporate for more than $840M

Enovis (NYSE:ENOV) announced today that it entered into a definitive agreement to acquire orthopedic implant maker LimaCorporate.

Wilmington, Delaware-based Enovis — one of the 10 largest orthopedic companies in the world — values the deal at approximately $846.4 million (€800 million). The deal includes a $740.6 million (€700 million) cash payment at closing. The remaining $105.8 million (€100 million) comes in the form of shares of Enovis common stock.

Lima, a global orthopedic company, develops digital innovations and patient-tailored hardware. It aims to empower surgeons and improve patient outcomes following joint replacement surgery.

Enovis says the addition of Lima establishes a $1 billion reconstruction business and expands its international scale. It also expects improved efficiency with state-of-the-art manufacturing facilities and a strong innovation engine. The company said the addition of Lima brings a complementary portfolio including 3D-pr…

Vicarious Surgical faces NYSE delisting

[Beta 2 surgical robotics system image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced that it received a notice regarding its compliance with the New York Stock Exchange (NYSE).

The Waltham, Massachusetts-based surgical robot maker received the notice on Sept. 20. It alerted the company that it is not in compliance with Section 802.01C of the NYSE Listed Company Manual. Vicarious Surgical’s average closing price of Class A common stock fell below $1 per share over a consecutive 30-trading-day period.

Vicarious said in a news release that the notice does not result in immediate delisting from the NYSE. It intends to respond to the exchange within 10 business days of receipt of the notice. The company said it intends to cure the stock price deficiency and return to compliance.

Adam Sachs, Vicarious Surgical CEO, will speak on a panel at DeviceTalks West next month. Learn more at West.DeviceTalks.com.<…

Dexcom, RxFood partner on AI-based nutrition, glucose monitoring for diabetes management

Within the RxFood app, Dexcom CGM users can capture photos of their meals. It eliminates the need for manual food and nutrition tracking. [Image courtesy of RxFood/Dexcom]Dexcom (Nasdaq:DXCM) announced that it teamed up with RxFood on a digital diabetes solution for people in Canada.

The first-of-its-kind partnership combines Dexcom’s continuous glucose monitoring (CGM) with RxFood’s AI-driven personalized nutrition assessments. The companies aim to introduce an improved digital health solution for people living with diabetes. It integrates food data with insulin dosing, exercise and glucose information.

RxFood made its next-generation app, featuring Dexcom CGM data integration, now available to healthcare program stakeholders in Canada. That includes clinics, hospitals, health authorities, pharmacies, insurers and employers. Through these programs, Canadians using the Dexcom G6 or G7 (once available) can access combined food and glucose data. It offer…

USMI to debut Canady surgical robot

The Canady robotic AI surgical system. [Image courtesy of USMI]US Medical Innovations (USMI) today announced plans to display its Canady robotic AI surgical system at the start of next year.

USMI announced the planned debut in collaboration with the Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS). They called the announcement “a ground-breaking achievement in surgical and robotic technology.” They plan to unveil the system at the First Global Surgical Oncology Summit in Jerusalem, Israel. It takes place between Jan. 30, 2024, and Feb. 2, 2024.

Canady delivers cold atmospheric plasma (CAP), a three-dimensional, non-contact biometric pulsed electromagnetic field. CAP selectively targets and kills microscopic tumor cells during surgery without damaging non-cancerous surrounding tissue.

The system features a motorized positioning arm, a speech recognition electrosurgical generator called ORLI and a con…

Insightec scores positive coverage for ultrasound-based essential tremor treatment

The Exablate Neuro system. [Image from Insightec’s website]Insightec announced today that Humana became the fifth national payor in the U.S. to cover its ultrasound treatment for essential tremor.

The Haiefa, Israel, and Miami, Florida-based company develops the Exablate Neuro system. It uses focused sound waves safely guided by MRI. The system provides tremor treatment to patients with medication-refractory essential tremor and Parkinson’s disease. Focused ultrasound has FDA approval to treat both sides of the body. The second treatment occurs at least nine months after the first side for eligible patients.

Humana’s coverage extends to ultrasound treatment for medication-refractory essential tremor.

“We are pleased that this positive decision will expand access to focused ultrasound for more commercial patients,” said Dee Kolanek, Insightec VP of market access and reimbursement. “We are grateful to top insurers like Humana for…

Akili launches its over-the-counter digital ADHD treatment for Android devices

A child uses the EndeavorRx digital therapeutic. [Image courtesy of Akili]Akili (Nasdaq:AKLI) today announced the over-the-counter (OTC) availability of its EndeavorOTC digital ADHD treatment.

Boston-based Akili last week announced a shift toward a non-prescription business model with its OTC offerings. In doing so, the company enacted a workforce reduction of approximately 40%. It included the elimination of the company’s field sales force and market access team.

That move followed a January workforce reduction of 30%, which totaled 46 workers. The company is one of many to slash headcounts as layoffs took medtech by storm recently.

Akili’s launch for EndeavorOTC comes on the Google Play market for popular Android devices. According to a news release, of the estimated 11 million adults with ADHD in the U.S., approximately 40% use Androids. The company believes this marks a crucial step in offering an accessible non-drug treatment option to adults wit…