Medical robotics startup Mendaera has purchased the technology of Avail Medsystems and hired some of its employees, Mendaera co-founder and CEO Josh DeFonzo said in an exclusive interview. The deal includes “substantially all” of Avail’s assets, said DeFonzo, who offered new details on his company’s objectives as it exits stealth mode. He declined to disclose […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems
Intuitive Surgical is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today. Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system. “We are planning for a limited launch starting in […]
FDA clears automated insulin delivery system from Sequel Med Tech
Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]
Intuitive wins FDA clearance for its next-gen da Vinci 5
Intuitive Surgical has secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system. The news, announced yesterday after market close, 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 […]
Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
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 […]
SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval. This isn’t the […]
Recall of Abbott HeartMate comms system is Class I
The FDA deemed a recall of the Abbott HeartMate Touch Communication System Class I, the most serious kind of recall. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero […]
FDA accepts Onward BCI into advisory program
Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology. Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a […]
FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system. The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. CellFX nsPFA’s percutaneous electrode system features a percutaneous needle […]
FDA clears Getinge’s cardiovascular surgery offering, company lanches new table, light in U.S.
Getinge this week announced a major FDA clearance and the beginning of a U.S. launch of multiple surgical tools. The Gothenburg, Sweden-based company won 510(k) clearance for its Vasoview Hemopro 3. This adds to the company’s portfolio of endoscopic vessel harvesting (EVH) solutions. Getinge said it designed the system with customer centricity top-of-mind. It hopes […]
Lumicell earns positive FDA panel decision on surgical imaging tool, approval decision expected soon
Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering. LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy. […]