MDIC Curates: Weekly Industry News Round-Up
Curated industry news detailing the latest within regulatory science and medical device innovation.
Q&A: The uses of etching in medical device manufacturing
MedTech News | August 23, 2022
Gary Marriot, technical sales manager for Advanced Chemical Etching Ltd (ACE), explains to Med-Tech Innovation News the uses of etching in the manufacture of medical devices…
FDA Approves Abbott’s New Spinal Cord Stimulation Device; Provides Tailored Relief to Multiple Pain Areas and Adds More Treatment Options for Evolving Pain Conditions
BioSpace | August 23, 2022
Abbott Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved its new Proclaim™ Plus spinal cord stimulation (SCS) system featuring FlexBurst360™ therapy. The next generation of Abbott’s proprietary BurstDR™ stimulation, FlexBurst360 therapy offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person’s therapeutic needs evolve….
Initiative to Improve next generation cancer diagnostics
Pharmfile | August 23, 2022
The Medical Device Innovation Consortium (MDIC) has formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project, aiming to improve the validation and regulatory review process for sequencing-based cancer diagnostics…
Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
JAMA Network | August 17, 2022
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder and is associated with adverse cardiovascular outcomes. A common subtype is persistent AF, defined as AF without interruption for at least 7 days. Randomized clinical trials have demonstrated clinical benefits with ablation compared with long-term medical therapy among patients with persistent AF. The 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society AF guideline indicates that catheter ablation is reasonable for some patients with symptomatic persistent AF, and approximately 30% of AF ablations are performed for this indication…
FDA Clears New Neurostimulation System for Chronic Pain
Medscape | August 23, 2022
The US Food and Drug Administration (FDA) has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced today…
Teleflex Strengthens Position in Bariatric Surgery with Acquisition
MDDI Online | August 23, 2022
Teleflex announced a definitive agreement to acquire bariatric surgery technology provider, Standard Bariatrics. The company is known for its bariatric stapling technology, the Titan SGS. Teleflex will acquire the company with an upfront payment of $170 million at closing, with an additional consideration of up to $130 million payable upon achievement of specific commercial milestones…
North America’s medical devices industry saw a drop of 22.52% in deal activity during July 2022
Medical Device Network | August 23, 2022
North America’s medical devices industry saw a drop of 22.52% in deal activity during July 2022, when compared with the last 12-month average, led by Amazon.com’s $3.9bn acquisition of 1Life Healthcare, according to GlobalData’s deals database…
Tele-mentoring used to improve surgical robotic systems training
Medical Device Network | August 23, 2022
Currently, there is a general recognition that the use of information and communication technologies is a potential resource to achieve the radical transformation required by health systems in the world. Included in this transformation is the great challenge of training new health professionals that include the development of surgical skills without endangering the lives of patients during this process…
Hemanext Launches Europeans Sales of Hemanext ONE® System in Italy and the Nordics.
Biospace | August 23, 2022
Hemanext signs agreements with leading European healthcare distributors to provide hospitals and clinicians with Hemanext ONE® system, marking the initiation of commercialization activities after CE Mark certification…
IRRAS Announces First Patient Treatments at Mount Sinai Health System in New York as Part of the DIVE Study
Biospace | August 23, 2022
IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient treatments with the company’s IRRAflow system within Mount Sinai Health System in New York, NY, one of the United States’ largest and most respected hospital groups. Thus far, two patients suffering from intraventricular hemorrhage (IVH) have been enrolled in the Deployment of Irrigating Intraventricular Catheter System (DIVE) clinical trial for patients. The DIVE study will assess the IRRAflow system’s ability to more effectively treat patients experiencing IVH than traditional treatment with an external ventricular drain (EVD)…
