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See what’s next from surgical robotics leaders on DeviceTalks Tuesdays

The FDA’s clearance of Intuitive’s Da Vinci 5 Surgical system will certainly be felt across a surgical robotics sector that’s already making great gains in securing FDA nods and building markets outside the U.S.

To provide a deeper look into some of the higher-profile surgical robotics companies, our DeviceTalks Tuesdays webinar series next week will stretch its traditional one-day format over three days, giving time and attention to three high-profile surgical robotics companies, including Intuitive.

Attendees to the event will get an inside look at how these companies view their place in the OR today and in the future.

DeviceTalks Tuesdays registration is free. Viewers watching live will be able to submit questions. On-demand viewing is available but questions won’t be allowed.

All sessions start at 12 p.m. Eastern time (9 a.m. Pacific time). Here is the lineup.

On Tuesday, March 19, Kathryn Rieger, PhD, senior director of human factors a…

The biggest diabetes tech news out of ATTD 2024

This is a screenshot from a video demonstrating the features of the new Roche Accu-Chek SmartGuide CGM at ATTD 2024.

Every year, the diabetes community comes together for the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

In the 17th installment at the start of this month, some of the biggest names shared new studies and technologies set to advance the diabetes space. Dexcom, Abbott, Medtronic and more contributed on their end, while some new technologies are coming to the fore as well.

Here are the biggest stories from this year’s ATTD conference in Florence, Italy. (You can also check out the biggest news out of ATTD in 2023 and 2022.)

Dexcom’s direct-to-watch feature

Dexcom announced at ATTD that it introduced a direct-to-Apple-Watch feature for its G7 continuous glucose monitor (CGM) users.

The company plans a phased launch for all G7 iOS users everywhere by the end of the second quarter of …

Delcath Systems announces $7M private placement

Delcath Systems (Nasdaq:DCTH) announced today that it entered into a securities purchase agreement worth $7 million in proceeds.

The company entered into an agreement with certain accredited investors for the private placement. The collection of investors includes existing investors, Delcath executives and members of the board of directors.

Delcath plans to issue and sell 876,627 shares of common stock at a price of $3.72 apiece. To certain investors, it intends to sell just over one million pre-funded warrants in lieu of shares of common stock. Those warrants enable the purchase of up to just over a million shares of common stock at a price of $3.71 apiece.

Pre-funded warrants have an exercise price of 1¢ per share of common stock, according to a news release. They’re immediately exercisable and remain exercisable until exercised in full.

Delcath expects gross proceeds of approximately $7 million before deducting offering expenses payable b…

Medtronic’s Respiratory Interventions unit president is leaving

Outgoing Medtronic Respiratory Interventions President Ariel Mactavish. [Image from Ariel Mactavish on LinkedIn]Ariel Mactavish, president of the Respiratory Interventions unit at Medtronic (NYSE: MDT) + , announced that she is departing her post at the medtech giant.

In a post on LinkedIn, Mactavish explained her decision to depart:

“After 12 rewarding years, I have decided to leave Medtronic and I want to take the opportunity [to] share my deepest gratitude for the amazing work of our team and their unwavering commitment to our patients and customers over the last several years together,” she wrote.

Mactavish’s departure comes shortly after Medtronic announced major changes within her unit. The company said last month that it plans to exit the ventilator market.

That decision came more than a year after Medtronic said it would spin off its Patient Monitoring and Respiratory Interventions b…

Fast Five: Edwards reports ‘excellent’ outcomes with Sapien TAVR; SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent

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, March 15, 2024.

Fast Five by MassDevice · Edwards reports new outcomes with TAVR; SafeGuard wins breakthrough nod for biodegradable stent

Conformal Medical this week reported “encouraging” results for its left atrial appendage occlusion device. Fast Five hosts Danielle Kirsh and Sean Whooley discuss what the device does and what doctors think about the device.

Autonomix has completed its first procedures in its pancreatic cancer ablation trial. Learn what the trial will assess, what the technology does and how optimistic executives are.

Axonics won CE mark approval for its fourth-generation rechargeable sacral neuromodulation system. Whooley talks about what the device does and some of the other news Axonics has had recently.

SafeGuard Surgical wo…

Intuitive wins FDA clearance for its next-gen da Vinci 5

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + announced today that it secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system.

The news comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here is our roundup of top surgical robotics companies.)

The da Vinci 5 joins Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5…

Better Therapeutics terminates staff as it seeks alternative options

Better Therapeutics (Nasdaq:BTTX) announced today that it is terminating its employees and will explore strategic alternatives.

Among those alternatives, the company could consider assignment for the benefit of creditors and/or a wind-down of the company. The San Francisco-based digital therapeutics maker came to the decision at a special meeting of its board on March 13.

It faces a similar fate to fellow digital therapeutic maker Pear Therapeutics, which scaled down operations after filing bankruptcy last year.

Better Therapeutics previously faced delisting from the Nasdaq market unless it regained compliance before a hearings panel. It now voluntarily requests the delisting and expects that to occur in the near term.

The decision to shut up shop follows an up-and-down stretch for the company, which managed multiple regulatory milestones recently. Its AspyreRx offering became the first cognitive behavioral therapy (CBT) to receive FDA authorizati…

What’s next for orthopedic device tech? Enovis’ CEO has ideas

Enovis CEO Matt Trerotola [Image courtesy of Enovis]“We’re excited about the momentum we’re building. We think we’ve made a good initial splash here,” Enovis CEO Matt Trerotola recently told MassDevice.

One of the largest orthopedic device companies in the world, Wilmington, Delaware–based Enovis has had a string of positive news lately:

Financial results swung to a profit as part of Street-beating fourth quarter 2023 results. The company expects further momentum as it integrates LimaCorporate and its patient-tailored, 3D-printed titanium implants for complex reconstructive surgeries. Enovis completed the $846 million acquisition in January. Enovis‘ DJO subsidiary in January launched its next-gen DonJoy Roam OA knee brace for osteoarthritis or other knee pain and instability. Enovis says it’s kicking off a multiyear cadence of new product introductions across its Recon and Prevention and Recovery (P&R) businesses.

Trerotola recently …

Conformal Medical reports ‘encouraging’ results for left atrial appendage occlusion device

The CLAAS implant. [Image courtesy of Conformal Medical]Conformal Medical announced “encouraging” results when comparing its CLAAS implant to the Boston Scientific Watchman FLX.

These left atrial appendage occlusion (LAAO) devices bring different things to the table. Made of foam, CLAAS features a cup design with an embedded nitinol skeleton covered by a fluoropolymer (ePTFE) cover. Watchman FLX’s nitinol frame is covered by a polyethylene terephthalate (PET).

Dr. William Gray presented an abstract on the comparison between devices at the Cardiovascular Research Technologies (CRT) 2024 conference.

The in vitro study compared the relative thrombogenicity of CLAAS compared to Watchman FLX. Investigators inserted three of each device into an acute radiolabeled in vitro blood loop system. After 90-120 minutes of exposure, investigators visually assessed the implants and measured the radiolabels.

Conformal Medical reported that CLAAS dem…

SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB

SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent.

Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first investors in the company. His investment marks a commitment to the stent as it could help communities of color disproportionately affected by colon cancer, SafeGuard said in a news release.

Dr. Scott Kelley developed the LeakGuard device belonging to Tampa, Florida-based SafeGuard. He said Pepin brings an “impressive track record” and dedication to initiatives that align with SafeGuard’s values.

“Tom’s leadership and resources will be instrumental in bringing this lifesaving technology rapidly to market,” Kelley said.

The patented biodegradable stent made from a medical-grade p…

Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system

The next-gen R20 rechargeable sacral neuromodulation system [Image courtesy of Axonics]Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.

The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. Axonics won FDA approval for this generation of the R20 in January 2023. The R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control. It also features enhanced programming capabilities with expanded MRI labeling.

R20 has a functional life in the body of at least 20 years and reduces charging frequency to every 6-10 months for just one hour.

Axonics expects to begin selling R20 to European customers in mid-April.

“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said CEO Raym…

Autonomix completes first procedures in pancreatic cancer ablation trial

Autonomix Medical announced today that it completed the first three patient procedures in a proof-of-concept trial of its ablation technology.

The Woodlands, Texas-based Autonomix designed its transvascular radiofrequency (RF) ablation technology to treat pancreatic cancer pain.

Current approaches to treat this pain include opioids or ethanol injections. However, Autonomix says those approaches may only provide limited relief and may lead to risky side effects. The company hopes its tissue ablation technology opens the door to a “novel, blockbuster disease treatment.” In January, Autonomix completed an animal study, leading to this proof-of-concept effort.

The company designed its catheter-based technology to perform two tasks. First, it senses neural signals associated with pain or disease. Then, it precisely targets those nerves for treatment.

Autonomix set out to successfully ablate somatic nerves and mitigate pain in its proof-of-concept trial…