Market Overview

FDA Reacts Positively to Private Sector Request for Faster Pre-Market Approval of New Medical Devices


PALM BEACH, Florida, March 4, 2019 /PRNewswire/ -- While many private sector industries in the U.S. vigorously denounce the government's intrusion, control and over-regulation on many matters, the largest complaint that reverberates is that the government just doesn't listen! Well… that is not the case in the U.S. medical device market. The FDA has listened and is taking action. A recent FORBES article reported: "… the U.S. Food and Drug Administration published the De Novo Classification Proposed Rule, which, if finalized, would establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures (21 CFR Part 860).  In an ever-changing healthcare  landscape, FDA seeks a new procedure that will let the market continue to develop but also offer a safe environment for the users. "The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health," said FDA Commissioner Scott Gottlieb. The move comes shortly after the FDA announced plans to modernize the medical device 510(k) clearance pathway."  Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ:SOLY), T2 Biosystems, Inc. (NASDAQ:TTOO), Medigus Ltd. (NASDAQ:MDGS), Cardiovascular Systems, Inc. (NASDAQ:CSII), Medtronic plc (NYSE:MDT).

The proposed regulation itself reads in part: "The proposed requirements establish procedures and criteria related to requests for De Novo classification ("De Novo request"). These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval."

Soliton, Inc. (NASDAQ:SOLY) BREAKING NEWS:  Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas M.D. on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has received notice from the U.S. Food and Drug Administration ("FDA") that the Company has qualified for the "Small Business" designation under the Medical Device User Fee Amendments ("MDUFA"). As a Small Business under the MDUFA, Soliton qualifies for a reduce or waived fee for medical device submissions made during the fiscal year 2019.  Join our more than 208K fans here to follow the Company:

Dr. Christopher Capelli, president and CEO of Soliton, said, "We are pleased to have qualified for Small Business status allowing us to receive reduced or waived fees for our FDA submissions. We appreciate the opportunity to submit device applications for review and approval at more favorable rates. In certain submissions, the savings could be dramatic. This helps us to operate more efficiently. Our plan is to is to submit our Rapid Acoustic Pulse ("RAP") device for tattoo removal for premarket clearance with the FDA under our new status in the near future."

The MDUFA rates cover a number of submissions that are routinely made to the FDA for review and approval. The rate table assigns fees for the fiscal year – which ends on September 30, 2019 – for the application type submitted for review along with the Standard Fee and the Small Business fee for companies that qualify for the designation.      Read this and more news for SOLY at   

Other recent developments in the Medical Device, healthcare, biotech industries:

The FDA has granted T2 Biosystems, Inc. (NASDAQ:TTOO) "Breakthrough Device" designation for the T2Resistance Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture.

The 13 genes identified on the panel include the most clinically important, as they are largely resistant to antimicrobial drugs that for certain patients, are crucial in the treatment of bacterial infections, including carbapenems, vancomycin, penicillin and more. Several of the genes detected by the panel are listed on the CDC's Urgent Threat list for antibiotic resistance.

Medigus Ltd. (NASDAQ:MDGS) (TLV: MDGS), a medical device company developing minimally invasive endo-surgical tools and an innovator in direct visualization technology, announced today that it has entered into a binding memorandum of understanding with Linkury Ltd., a leading company in the field of online advertising, which is wholly owned by Algomizer Ltd. (ALMO). As part of the memorandum of understanding Linkury will establish a commercial technological platform for the manufacturing, marketing and distribution of cannabidiol based (CBD) products. In addition, the two companies will examine entering into a definitive agreement and the formation of an international advertisement company, which will carry out the joint venture.

Cardiovascular Systems, Inc. (NASDAQ:CSII) was up over 9% at $39.50 in early trading today with over 399,000 shares traded by 10:10am EST. Cardiovascular Systems, a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced this year that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the Diamondback 360® Coronary Orbital Atherectomy System (OAS) with Classic Crown (Classic Crown) and ViperWire Advance® Coronary Guidewire FlexTip (FlexTip).

According to Zacks, Medtronic plc (NYSE:MDT) recently announced the launch of the Grafton demineralized bone matrix (DBM) bone grafting product in Japan. It is used for spinal and orthopedic procedures. The launch came on the heels of the PMDA (Pharmaceuticals and Medical Devices Agency) approval acquired by the company last August.

Medtronic is confident about a successful rollout of this product in Japan which happens to be the world's second largest market for spinal devices used in medical procedures. Notably, Grafton DBM is the first and only demineralized bone matrix product accessible in Japan.

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