Carlsmed announced today that it raised $52.5 million in a Series C funding round co-led by B Capital and U.S. Venture Partners. The Carlsbad, California-based AI-enabled personalized surgery company plans to use the funds to accelerate commercialization efforts. It wants to boost the commercialization of its aprevo personalized spine surgery platform for lumbar fusion procedures, […]
Implants
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 […]
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. […]
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 […]
Former Stimwave CEO convicted of healthcare fraud
The U.S. Justice Dept. announced last week that a jury found former Stimwave CEO Laura Perryman guilty of healthcare fraud. Damian Williams, U.S. Attorney for the Southern District of New York, last week announced the jury’s verdict. It found Perryman guilty on two counts of an indictment charging her with conspiracy to commit healthcare fraud and […]
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 […]
Ascensia, Senseonics announce new CGM cost savings
Ascensia Diabetes Care and Senseonics today announced an extension to their Eversense Payment Assistance and Simple Savings (PASS) program. The program aims to help people in the U.S. access the Eversense E3 continuous glucose monitor (CGM) more affordably. It offers major savings for eligible individuals looking to experience the benefits of the long-term, implantable CGM. […]
Affluent Medical touts first implant of artificial urinary sphincter
Affluent Medical today announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device. Dr. Roman Zachoval completed the first implant of Artus, an artificial urinary sphincter. Zachoval, head of urology at Thomayer University Hospital in Prague, implanted Artus in a 68-year-old male patient with severe urinary incontinence. The procedure lasted about 80 […]
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 […]
Endotronix has positive pulmonary artery sensor data
Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Orthofix beats Street in Q4, analysts see positive signs for future
Orthofix Medical are up today on fourth-quarter results that topped the consensus forecast. The Lewisville, Texas–based company posted losses of $22.2 million in the quarter. That equals 59¢ per share on sales of $200.4 million for the three months ended Dec. 31, 2023. The company’s bottom line dipped by more than $15 million further into […]