Medical Devices: Page 147
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EU Parliament panel adopts MDR delay for some Class I devices, full nod likely
One committee member called out the unusual nature of making late-in-the-game substantive regulatory changes through the corrigendum, a procedure typically meant for correcting technicalities and inconsistencies.
By Dana Elfin • Dec. 4, 2019 -
FDA commissioner nominee backs 'proactive, not passive' approach to device safety
While Stephen Hahn shed more light on his thoughts on certain medical device topics, he declined to say FDA scientific judgments of medical devices should be held to the same regulatory standards as drugs in response to a question.
By David Lim • Dec. 4, 2019 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Contract sterilizer of devices draws FDA warning over validation issues
American Contract Systems received multiple complaints about the presence of foreign matter in sealed sterilization bags, the agency said.
By Nick Paul Taylor • Dec. 4, 2019 -
Medtronic and Elekta form radiation therapy pacts with ViewRay
ViewRay's plans to raise $75 million should help reduce concerns surrounding the company's liquidity, analysts at Jefferies said.
By Nick Paul Taylor • Dec. 3, 2019 -
FDA seeks public input on pediatric device applications including ways to minimize burden
The agency said it expects to receive about 47 original premarket approval, product development protocol or humanitarian device exemption submissions each year. About 11 submissions will lack required pediatric use information.
By Susan Kelly • Dec. 2, 2019 -
Courtesy of Sanofi
Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier
The company said it will immediately begin integrating the product, meant to reduce adhesion barriers in patients having abdominal or pelvic laparotomy procedures, into its advanced surgery business.
By Maria Rachal • Updated Feb. 18, 2020 -
GE Healthcare bulks up in 3D printing, robotics, patient monitoring
Projecting up to $20 billion in revenues this year, GE Healthcare is aiming to capitalize on the shift toward more precision in patient care with investments in Formlabs, CMR Surgical and Decisio Health.
By Susan Kelly • Dec. 2, 2019 -
Dexcom server outage rocks Type 1 diabetes community
The company announced late Monday it has restored services for its Dexcom Follow app to "near normal performance." Dexcom said it will work to improve communication methods with its customers.
By David Lim • Updated Dec. 3, 2019 -
Intuitive gets FDA go-ahead for robotic system sealing instrument, power generator
The devices add to the capabilities of Intuitive's da Vinci X and Xi as the robotic surgery giant works to grow recurring revenues and stave off competition.
By Nick Paul Taylor • Dec. 2, 2019 -
EU MDR delay for certain Class I devices moves forward: what it means for manufacturers
"The Corrigendum will remove some pressure for these manufacturers" to obtain a CE Certificate of Conformity from a notified body, Fabien Roy and Elisabethann Wright of Hogan Lovells said.
By Dana Elfin • Nov. 27, 2019 -
Roundup: How major medtechs fared in Q3
A still robust economy, coupled with caution regarding a potential recession, is working in medtech's favor as the sector outperforms the S&P 500.
By Maria Rachal • Nov. 27, 2019 -
B. Braun recalls blood sets over risk of leakage and infection
Leaks in the 43,000 devices could delay treatment or lead to blood infections.
By Nick Paul Taylor • Nov. 27, 2019 -
With 6 months until new EU medical device rules, what's the state of play?
Preparing for the May 26, 2020, implementation of the EU's Medical Device Regulation hasn't been easy, given the lack of notified bodies designated to review devices under the more stringent standards.
By Dana Elfin • Updated Nov. 26, 2019 -
Standards body urged to add device identifiers to insurance claims forms
Incorporating unique device identifiers into claims documents is expected to improve patient safety and save the healthcare system money by allowing better tracking of implants by brand and model.
By Susan Kelly • Nov. 26, 2019 -
FDA approves J&J spinout's device for kids with recurring ear infections
The agency heralded Tusker Medical's ear tube delivery system as the first for use in young children with local anesthesia in a doctor's office, which could widen treatment access for a "susceptible patient population."
By Maria Rachal • Nov. 26, 2019 -
Medtronic warns of fault with MiniMed insulin pumps
The structural fault could cause too much or too little insulin to be delivered. The issue stems from the loss of or damage to the retainer ring, which Medtronic said can break if the pump is dropped or bumped.
By Nick Paul Taylor • Nov. 26, 2019 -
Danielle Ternes/MedTech Dive
Q&A5 insights into Dexcom's year ahead from CEO Kevin Sayer
The diabetes tech giant has "not turned on the faucet full blast" in marketing to new customers. Sayer told MedTech Dive he plans to change that as Dexcom quadruples its sensor production capacity for its continuous glucose monitors.
By Maria Rachal • Nov. 25, 2019 -
Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis
Antibiotic resistance was higher in hospital-associated infections linked to use of devices like central lines, ventilators and urinary catheters, according to data collected from more than 5,600 sites between 2015 and 2017.​
By Susan Kelly • Nov. 25, 2019 -
FDA launches pilot to speed new ethylene oxide sterilization methods
Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.
By David Lim • Nov. 25, 2019 -
Retrieved from U.S. Environmental Protection Agency.
AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs
A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.
By David Lim • Nov. 22, 2019 -
Jacob Bell/MedTech Dive
Merit Medical stent graft system gains breakthrough status
The regulatory leg up for the endoprosthesis for hemodialysis patients comes after a quarter that fell short of Wall Street's expectations.​
By Nick Paul Taylor • Nov. 22, 2019 -
Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV
The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous access in dialysis patients.
By Nick Paul Taylor • Nov. 22, 2019 -
Transcatheter device to treat heart failure gets breakthrough designation
BioVentrix is enrolling 120 subjects in a clinical trial meant to support U.S. marketing authorization for its minimally invasive alternative to conventional surgical ventricular reconstruction.
By Nick Paul Taylor • Nov. 21, 2019 -
Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology
After reviewing more than 4,000 cases of mitral valve repair, researchers proposed exploring intervention with devices like Abbott's MitraClip earlier in disease progression to improve outcomes.
By Nick Paul Taylor • Nov. 21, 2019 -
Trump FDA nominee Hahn advanced by Senate HELP Committee 18-5
Ranking Member Patty Murray said she would not support the nomination due to a lack of a commitment to back regulations to take non-tobacco flavored e-cigarettes that have not gone under FDA review off the market.
By David Lim • Updated Dec. 3, 2019
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