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
Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold
Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
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 […]
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 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 […]
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
Stereotaxis submits Magic ablation catheter for U.S., European approval
Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval. The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]