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Friday, January 18, 2019

Device Industry Breaking News

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Precision Therapeutics Receives $1,370,000 Investment from CEO and Director, Carl Schwartz

1/18/19: As part of the investment, which is detailed in a Form 8-K filed with the United States Securities and Exchange Commission on January 14, 2019, Mr. Schwartz also received additional warrants to purchase Company common stock.

Preliminary Study Finds Healbe GoBe2 Offers Accuracy in Measuring Calorie Intake

1/18/19: The study showed the technology to be about 89 percent accurate in automatic tracking of digested calories. A 14-day study was completed by 27 adult volunteers between the ages of 18-40 years old, 11 men and 16 women.

HighLife Closes a €32 Million Round B Financing

1/18/19: Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study.

Pulse Biosciences Announces Two Appointments Focused on CellFX™ Commercialization: Promotion of Edward Ebbers and Addition of Robert Tyson

1/18/19: The leadership pair brings more than 35 years of combined experience commercializing novel technologies in the aesthetic dermatology market and the necessary skillsets to launch and scale the CellFX System and its growing pipeline of applications into the aesthetic dermatology market.

Itamar Medical Announces Definitive Agreements for $11.5 Million Private Placement

1/17/19: Net proceeds of the financing will be used primarily to accelerate the Company’s revenue growth through direct expansion of its sales and marketing initiatives.

Perceval Aortic Heart Valve Study North American Results Published in Journal of Thoracic and Cardiovascular Surgery

1/17/19: The multi-center, prospective, non-randomized, single-arm clinical trial included 300 patients from 18 U.S. centers.

First Patient Enrolled in Clinical Study to Assess Pain Control and Oral Opioid Elimination with Targeted Drug Delivery

1/17/19: Embrace TDD clinical study will evaluate the use of the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain with or without leg pain.

Baxter Announces 5 Million Home Dialysis Treatments Managed Globally with Sharesource Remote Patient Management

1/17/19: Baxter’s Sharesource remote patient management platform has logged more than 5 million home peritoneal dialysis treatments globally; milestone is evidence that smarter, more effective innovation is enhancing renal care.

First FDA Cleared System for Remote Diagnostic Reading of Radiological Images Breakthrough

1/17/19: The company submitted the Rad@ application with FDA in 2016 and was granted clearance in January 2017. As a result, radiologists can now interpret images and make diagnosis independent of their location.

First Cancer Patients in Taiwan Treated with Varian HyperArc High-Definition Radiotherapy

1/17/19: HyperArc™ High Definition Radiotherapy (HDRT) is a new type of radiosurgery treatment solution reports Varian.