Scryb Inc. Forum: Community User: Philipp85

Hallo zusammen, ich habe Antwort wegen BaFin und der FDA-Zulassung bekommen. Siehe unten. Hi, Apologies for not responding to you earlier. We must have missed the facebook notification over the holidays. In regards to your first question about the FDA process. HemoPalm will be class II device just like iStat and Epocal devices currently on the market and will follow the same approval process. This approval process (FDA 510(k )) basically requires proof that the device substantially equivalent to a legally marketed device that is not subject to Premarket approvals. Applicants must compare their device to one or more similar legally marketed devices and make and support their substantially equivalent claims. If the device is substantially equivalent to an approved medical device, it is placed in the same class. If it is not substantially equivalent, it becomes non-SE and is placed into Class III. Members of the ChroMedX development team have done several successful FDA 510(k ) applications before including a handheld blood analyzer very similar in core-functionality to the HemoPalm. The US FDA is by far the most important approval as it is the largest market but the technology will also require Health Canada and CE approvals for sale in Canada and Europe. The FDA process starts once the pre-production device is complete. In regards to your second question about the BaFin warning. The Company is aware of this and ChroMedX council in Frankfurt are working with BaFin now to investigate what the issue was. This is a warning in regards to coverage of ChroMedX being potentially misleading NOT information issued by the Company. ChroMedX disseminates its news only through accredited dissemination and translation services. Our news is always posted and available on our website and eblasted in a timely fashion in accordance with standard regulatory practices. If you are concerned about anything you read or have questions please email investor relations at info@chromedx.com Thanks,

Ja glaube ich auch :) Es müssten bald News kommen!

Hemopalm wird sich durchsetzen und dann sehen wir hier ganz andere Kurse!

Handelsvolumen besser als die letzten paar Wochen

Zieht an!

Aus dem hause pollinger?

https://www.wallstreet-online.de/nachricht/10165939-best-of-2017-aktien-aktien-kaufen KAUFEN: CHROMEDX CORP. (WKN: A12B6G) Vom Pennystock zum Superstar der Branche – diese Reise hat bei ChroMedX erst begonnen – JETZT, in den letzten Wochen! Warum diese Aktie für mich immer noch ein Kauf ist, erfahren Sie in meinem letzten Blogbeitrag: Die beste Aktie, die Sie heuer noch kaufen können. Zwei echte Fachexperten Experten machen sensationelle Aussagen über die Technologie! Dr. Thomas Schumpberger: „Eine echte Revolution! Wir haben gleich erkannt, dass wir es hier mit einem POCT-Blutgasanalysegerät der nächsten oder dritten Generation zu tun haben…” ...

In Kanada plus 10,71%

Wird erst bei News wieder in Bewegung kommen (Zulassung etc.)...bin gespannt

Wo denn? DIE STEHT EHER

Endlich wieder Bewegung drin

CSE: CHX / OTCQB: CHXIF ChroMedX Featured in TechOfficials.com Interview with DxEconomix Inc. December 22, 2017 – ChroMedX Corp. (the “Company”) (CSE: CHX, OTC: CHXIF, Frankfurt: EIY2), developer of the HemoPalm Handheld Blood Analyzer System, has been featured in a TechOfficials.com featured article with DxEconomix Inc. The TechOfficials.com featured article features an interview with DxEconomix Inc. management, CEO Dr. Richard Janeczko and Director Thomas Schlumpberger. The full English interview titled “This is a Game Changer!”: MedTech Exec’s Talk Health Economics and the Evolution of Critical Care can be found at http://techofficials.com/medtech-execs-talk-health-economics-evolution-critical-care/ A german translation of the interview can be found here: http://techofficials.com/revolution-medtech-fuhrungsexperten-sprechen-uber-gesundheitsokonomie-und-die-evolution-der-intensivmedizin/ About ChroMedX Corp. ChroMedX Corp. is a medical technology company focused on the development of novel medical devices for in vitro diagnostics and point-of-care testing.  The devices are protected by the Company’s issued and pending patents, dealing with blood collection, analysis and plasma/serum processing. The HemoPalm Handheld Blood Analyzer System is the only handheld blood analysis technology which combines Blood Gases & Electrolytes with full CO-oximetry.  Currently this combination is not available on any of the handheld analyzers on the market. Existing technologies require users to purchase a second device to carry out the CO-oximetry. The Company’s technology has the advantage of being able to offer a single handheld blood analyzer that provides all the required tests for Blood Gases & Electrolytes, with full CO-oximetry and bilirubin. Another competitive advantage of the HemoPalm system will be its ability to draw capillary blood directly from a pin-prick site into the cartridge, providing an alternative to arterial blood. Drawing arterial blood is painful and can cause nerve damage. CO-oximetry is the measurement of five different hemoglobin species in blood.   The global market for Blood Gases & Electrolytes was estimated to be 1.5 Billion $US in 2015 and is projected to reach over 1.8 Billion by 2020. Contact: Investor Relations Office. 647-872-9982 ext. 2 TF. 1-844-247-6633 ext. 2 investor.relations@chromedx.com NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Forward-looking Information Cautionary Statement Except for statements of historic fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company's control. The Company undertakes no obligation to update forward-looking information if circumstances or management's estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company's filings with Canadian securities regulators, which filings are available at www.sedar.com www.chromedx.com ChroMedX Corp. ChroMedX Corp. Suite 520, 65 Queen Street West Toronto, ON M5H 2M5, Canada Unsubscribe

Bei der FDA unter https://www.fda.gov/aboutfda/workingatfda/ethics/ucm079670.htm findest du ChroMedX bereits als Significantly Regulated Organization. Das heisst ihr Geschäft hat oder wird prüfungspflichtig durch die FDA sein... was wir ja auch schon wussten. Im schlechtesten Fall müssen wir bis März (16 Wochen nach Beauftragung der Ants Kahu & Associates am 13.11.17) warten, bis geprüft wurde, ob die internen Prozesse zur Qualitätssicherung https://www.johner-institut.de/blog/wp-content/uploads/2017/04/21-CFR-part-820-QSR.png auch dokumentiert sind.

News

Du kannst trotzdem bei der DiBa kaufen. Du musst über Service den Auftrag manuell einstellen und bestätigen, dass du die Warnung bez. BaFi erhalten hast. Tust du dies führen sie den Auftrag aus.

3 Monate Sperre bei die ing diba, danach kannst du wieder kaufen