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Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations

FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.

Policy & Regulation Regulation Legislation

Manufacturers Scramble To Meet Looming Unique Device Identification Deadline – But Too Many Are Unprepared, Insiders Claim

US FDA and device industry experts are concerned that too many firms are woefully unprepared for, and undereducated about, the agency's Unique Device Identification program. A recent industry survey appears to bear this out: A whopping 85% of respondents say they're not ready for the upcoming UDI compliance deadline of Sept. 24 for makers of class II products. Meanwhile, firms asking for UDI exceptions for their devices are waiting an inordinate amount of time for FDA to come to a decision, in part because the agency simply doesn't know how to publicly disclose the exemptions, UDI guru Jay Crowley says. Also: experts mull over the agency's latest UDI guidance; FDA explains why using an HL7 UDI submission option for its GUDID database isn't a good idea for every firm; and Crowley discusses what the UDI landscape will look like in 2020.

Medical Devices Quality Control Manufacturing Quality

Start-Up Spotlight: MagDent, Electromagnetic Healing Cap For Dental Implants

Israeli start-up MagDent Ltd. has developed a miniaturized electromagnetic healing cap designed to stimulate and improve bone formation at the site of dental implants.

Dental Oral Innovation Companies

Device Week – August 17, 2016

On this week's podcast, Ashley Yeo discusses the state of medtech in the UK two months after the country voted to leave the EU. Stakeholders are using the summer months to weigh alternatives and map out positions, he explains, in preparation for accelerated Brexit activity anticipated this fall.

United Kingdom Brexit Regulation
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Policy & Regulation

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PODCAST: Penning FDA-483 Responses Can Be Tricky – But Not For Device Firms That Follow These Tips

Industry insider Steve Niedelman tells device manufacturers how they should respond to US FDA after receiving an FDA-483 following an unfavorable facility inspection in this Medtech Insight podcast.

Policy & Regulation Quality Control Medical Device

Warning Letter Roundup & Recap – Aug. 23, 2016

Ohio diagnostics importer Tosoh Bioscience told by US FDA to hire a consultant to audit its quality system in the only warning letter released by the agency this week.

Quality Control Policy & Regulation Medical Device

Latest From Policy & Regulation

Despite New De Novo Clearance To Assess Brain Injury, ImPACT Concussion Assays Have Been Used For Years

US FDA granted a de novo clearance for ImPACT Applications's ImPACT and ImPACT pediatric tests to assess a patient's cognitive functions for suspected brain injury on Aug. 22, defining a new class of device, "Computerized Cognitive Assessment Aid For Concussion", but the devices have actually been in widespread use by health care providers on behalf of US parents, sporting teams, and schools since 2006, the company tells Medtech Insight.

Regulation Medical Device

South African Reimbursement Guidance Explains What Can 'Make-Or-Break' Applications

South Africa’s medical device industry association SAMED explains how medical device companies can make the most of their applications for reimbursement.

South Africa Policy & Regulation

Workshop To Address NGS Draft Guidances

US FDA is holding a workshop at NIH headquarters on Sept. 23 to get public feedback on two important draft guidances that provide sponsors with more clarity on the agency's thinking on next-generation sequencing tests.

North America United States

Commercial

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Getinge Ousts CEO Mid-Restructure

Getinge is looking for a new CEO after deciding to jettison Alex Myers from the helm, less than 18 months after he took up the top executive role.

Surgery Companies Commercial

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NSF International Names Former FDA Deputy Director As Executive VP

Regulatory compliance consulting firm NSF International recently appointed Heather Howell, a former deputy director for communications within US FDA’s device center, to serve as executive VP of training and internal quality management systems for the firm’s medical device group in DC.

Commercial Medical Device

Zimmer Biomet Adds CD Diagnostics To List Of 2016 Acquisitions

The deal will add musculoskeletal diagnostic tests to Zimmer Biomet's new Signature Solutions consulting and technology program. It is the orthopedics giant's sixth acquisition of 2016.

Orthopedics In Vitro Diagnostics

From Pipe Dream To Reality: Artificial Pancreas Set To Debut

Medtronic is leading the race to get an artificial pancreas to market, and by this time next year the company could be the first manufacturer to reach the finish line. The achievement would be historic, but with a group of established and young companies running about two to three years behind, Medtronic will have to continue to improve on its offerings to maintain its impressive dominance.

Diabetic Care Metabolic

Clinical R&D

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Advanced ICU Care Launches Cardiac Telemetry Service

Advanced ICU Care, the largest provider of tele-ICU services in the US, will now also provide "census-variable" real-time telemetry monitoring for patients at risk for cardiac events, allowing hospitals to outsource this vital service while paying for it on a per-patient basis.

Cardiovascular Innovation Companies

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Fractyl's Novel Diabetes Treatment Clears First Hurdle In Clinical Trial

The first-in-human study of Fractyl's Revita duodenal mucosal resurfacing system shows significant short-term improvement in hyperglycemia in patients with type 2 diabetes, with few adverse events.

Research & Development Clinical Trials

Arch Therapeutics Closes In On CE Mark For Novel Blood Control Agent

Securing the CE mark for its topical hemostatic agent has taken Arch Therapeutics longer than expected, but the company now predicts filing for a CE mark by the end of 2016, and is looking for a partner to help commercialize it in Europe.

Dermatology Clinical Trials

US FDA Approves First Intermediate-Risk Indication For TAVR

The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.

Research & Development Approvals
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