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Regulatory News

Real World Evidence: FDA Finalizes Guidance on Using EHRs in Clinical Studies
Every clinical use of a product produces data that can help better inform us about its safety and efficacy. This guidance facilitates the use of electronic health record data in clinical investigations and helps integrate data collected in routine care settings into clinical trials
(RAPS 07/18/18) RWE

FDA advances three important initiatives to support medical device development, innovation, and safety
The initiatives include a finalized program for manufacturer reporting of certain device malfunction medical device reports in summary form, prioritizing resources on devices that pose higher risks to public health, and draft guidance to provide more clarity concerning the FDA’s issuance of Certificates to Foreign Government.
(FDA 08/16/18) General 

FDA user fees set to rise 4% in fiscal 2019
Medical device makers pay user fees to have the FDA review their products. For fiscal 2018, the rates jumped by more than 33%, with the fee for one popular protocol jumping more than 125%.
(MassDevice 07/30/18) General 

Europe’s Eudamed Database: Five Key Questions
The go-live date for Eudamed is set on March 26, 2020 and will be functional for both medical devices and IVDs. From May 26, 2020 for medical devices, and May 26, 2022 for IVDs, it is required to enter new or modified data in Eudamed, including data that is directly linked to these records. During a period of 18 months after the date of application of Eudamed the database must be filled with data on the rest of the devices that are placed on the European market.
(Emergo 08/06/18) RWE

Report: ICS-CERT tags 2 Medtronic devices with cybersecurity vulnerabilities
ICS-Cert said that the MyCareLink patient monitor insufficiently verifies data authenticity and allows passwords to be stored in a recoverable format. Such vulnerabilities could allow someone with physical access to the device to obtain product credentials used to upload data to Medtronic’s network, and would allow for the submission of false, forged data to the network. Medtronic said it is not planning to address the vulnerabilities.
(MassDevice 08/09/18) Software

Combo Products: FDA Delays Compliance Date for UDI Submissions
Compliance date for the device components of co-packaged and cross-labeled combination products relates to the requirements on data submissions to FDA’s Global UDI Database (GUDID) under the 2013 UDI regulation was extended from September 24, 2018 to September 24, 2019.
(RAPS 08/09/18) General 

Report: FDA’s Gottlieb says pediatric device approvals are lagging
FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population. Barriers including sample size issues, regulatory concerns and problems with research infrastructure are keeping such devices from hitting the market, according to an audience poll from the workshop.
(MassDevice 08/15/18) Pediatrics

Health Canada Proposes ‘Pause the Clock’ Mechanism for Premarket Submissions
Within the proposed model, it is anticipated that clock pauses would be triggered only under defined circumstances; therefore would not routinely add to the total time to decision. In some circumstances, a pause could avoid the submission receiving a negative decision.
(RAPS 08/15/18) General 

FDA’s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs
Voluntary Malfunction Summary Program seeks to streamline the way in which malfunctions are reported while still giving the agency enough information to effectively monitor devices. Eligible manufacturers would only have to submit certain medical device reports related to device malfunctions in summary form on a quarterly basis for certain product codes.
(MedTech Intelligence 08/16/18) General 


Payment News

CMS proposes nixing pain management questions from HCAHPS in response to opioid epidemic
CMS is planning to eliminate a set of questions on pain management from its nationwide patient experience survey. The questions ask patients if they experienced pain during a hospital stay and if they felt the care team communicated with them adequately about it. According to the rule, questions could potentially impose pressure on hospital staff to prescribe more opioids in order to achieve higher scores on the HCAHPS survey.
(FierceHealthcare 07/31/18) Pain Management

Senators examine causes of rising improper payments to Medicaid
Examination from Congress follows a Government Accountability Office report from April estimating that federal Medicaid funds on the order of $37 billion had been improperly paid.
(MedPage Today 08/21/18) Pediatrics | General 

CMS Awards $8.6 Million in Funding to States to Help Stabilize Markets
State grants awarded intend to help strengthen the private health insurance market through innovative measures such as conducting economic analyses and market scans of the State’s health insurance market to improve affordable coverage and examination of plan policies related to access to mental health and substance use treatment services.
(CMS Newsroom 08/20/18) General 


MarketWatch

Sanofi Ventures leads $17M round for Click Therapeutics
The company’s commercial product, Clickotine, is designed to help people quit smoking. The digital smoking cessation program uses a personalized plan to help people overcome tobacco cravings, adhere to medication regimens and connect with people in a support network.
(MassDevice 07/23/18) Software

Adhesive respiratory monitor detects breathing problems early
A new device, recently cleared by the FDA for children 1 year and older in medical settings, provides an easy, noninvasive way (via minute ventilation) to tell how much air the lungs are receiving in real time. It can signal problems as much as 15-30 minutes before standard pulse oximetry picks up low blood oxygenation, according to one study.
(MassDevice 07/25/18) Pediatrics | Injury Prevention

NanoVibronix touts trigeminal neuralgia PainShield study data
The PainShield is a device designed to treat pain in nerves, muscles and joints through the delivery of localized ultrasound.
(MassDevice 07/25/18) Pain Management

ElectroCore Is Changing the Game in Bioelectronics
GammaCore Sapphire is a non-invasive vagus nerve stimulator for the acute treatment of pain associated with migraine and episodic cluster headache. Each month patients will receive an RFID card, much like a hotel key that will be placed against the device and it authorizes the device to work for another 31 days. The firm is beginning to look at other indications outside of migraines, which include applications in neurology and rheumatoid arthritis.
(MDDI 08/01/18) Pain Management

Masimo touts study exploring pulse oximetry pre-screening for OSA in children with down syndrome
Masimo released results from a study exploring home pulse oximetry monitoring’s ability to serve as an initial screening method to determine which children with Down syndrome should be recommended to undergo sleep studies to diagnose obstructive sleep apnea.
(MassDevice 08/14/18) Pediatrics | Injury Prevention

MolecuLight wins FDA de novo nod for handheld fluorescence wound imager
MolecuLight i:X is designed to assess wound surface area and help visualize harmful bacteria within the wounds. The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.
(MassDevice 08/15/18) Injury Prevention

Kleresca wins CE Mark for biophotonic dermatological system
The Kleresca biophotonic system uses fluorescent light energy to stimulate biological processes and repair mechanisms in the skin.
(MassDevice 08/17/18) Injury Prevention

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Research Engineer and Cassie Brugger, MA, Simbex Centers Senior Program Administrator.  A story’s inclusion does not imply endorsement by Simbex, LLC.

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